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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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QinFlow Warrior Extreme system - 07290016740080

QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body.The kit contains 1 battery. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
QIF-01-12 kit
In Commercial Distribution

  • 07290016740080 ()
Q1210S0000U

  • Conduction blood/fluid warmer
  • Conduction blood/fluid warmer set

QinFlow Warrior Extreme Blood and Fluid Warmer Base Unit (BU) - 07290016740073

QinFlow Warrior Extreme Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.
QUALITY IN FLOW LTD
QIF-01-12
In Commercial Distribution

  • 07290016740073 ()
QPORT1100U12

  • Conduction blood/fluid warmer

QinFlow Enhanced Battery - 07290016740066

QinFlow Li-ion rechargeable Battery
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 07290016740066 ()
QPORT1180U

  • Portable/mobile rechargeable battery pack

QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU) - 07290016740028

QinFlow Blood and Fluid Warmer QiF-01 Disposable Unit (DU) is a disposable cartridge, provided sterile and ready for use. Inside the cartridge there is a tube which the fluid/blood flow through it and heated by it. While operation, the DU is connected to the Base Unit using a cable. The Disposable Unit has a standard intravenous tube extensions.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 17290016740025 ()
  • 07290016740028 ()
QPORT1200U

  • Conduction blood/fluid warmer set

QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU) - 07290016740011

QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 07290016740011 ()
QPORT1100U

  • Conduction blood/fluid warmer

QinFlow Blood and Fluid Warmer QiF-01 Compact Disposable Unit (DU) - 37290016740050

QinFlow Blood and Fluid Warmer QiF-01 Compact Disposable Unit (CDU) is a disposable cartridge, provided sterile and ready for use. Inside the cartridge there is a tube which the fluid/blood flow through it and heated by it. While operation, the CDU is connected to the Base Unit using a cable. The Compact Disposable Unit has a standard intravenous tube extensions.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 37290016740050 ()
  • 17290016740056 ()
  • 27290016740053 ()
  • 47290016740057 ()
QPORT0500U

  • Conduction blood/fluid warmer set

MEDLINE - 10197344129089

COMFORTTEMP GOWN, XL
MEDLINE INDUSTRIES, INC.
CTGOWNXL
In Commercial Distribution

  • 20197344129086 ()
  • 10197344129089 ()
CTGOWNXL

  • External circulating-air core temperature regulation system pad, single-use

MEDLINE - 10197344129072

COMFORTTEMP GOWN, STANDARD
MEDLINE INDUSTRIES, INC.
CTGOWNSTD
In Commercial Distribution

  • 20197344129079 ()
  • 10197344129072 ()
CTGOWNSTD

  • External circulating-air core temperature regulation system pad, single-use

PRISMAFLEX - 07332414126766

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
7.21
Not in Commercial Distribution

  • 07332414126766 ()
955792

  • Haemodialysis system, institutional

Prismaflex - 07332414124236

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
GAMBRO AB
7.20
In Commercial Distribution

  • 07332414124236 ()
955542

  • Haemodialysis system, institutional

Prismaflex - 07332414117702

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
GAMBRO AB
7.XX
In Commercial Distribution

  • 07332414117702 ()
115269

  • Haemodialysis system, institutional

Prismaflex - 07332414105266

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
5.XX
Not in Commercial Distribution

  • 07332414105266 ()
113081

  • Haemodialysis system, institutional

FLC Lambda - 03607360051030

No Description
SEBIA
5103
In Commercial Distribution

  • 03607360051030 ()
5103

  • Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA)

FLC Kappa - 03607360051023

No Description
SEBIA
5102
In Commercial Distribution

  • 03607360051023 ()
5102

  • Kappa/lambda light chain immunoglobulin IVD, kit, enzyme immunoassay (EIA)

HYDRAGEL 54 PROTEINE MAXI KIT - 03607360042601

PROTEIN SEPARATION
SEBIA
4260
In Commercial Distribution

  • 03607360042601 ()
4260

  • Protein electrophoresis IVD, kit, electrophoresis

HYDRAGEL 54 B1-B2 - 03607360041468

PROTEIN SEPARATION
SEBIA
4146
In Commercial Distribution

  • 03607360041468 ()
4146

  • Protein electrophoresis IVD, kit, electrophoresis

HYDRAGEL 30 PROTEIN(E) - 03607360041406

Protein separation
SEBIA
4140
In Commercial Distribution

  • 03607360041406 ()
4140

  • Protein electrophoresis IVD, kit, electrophoresis

QinFlow portable warmer system - 17290016740032

QinFlow portable warmer system - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body.The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 17290016740032 ()
QPORT1000U-1

  • Conduction blood/fluid warmer set
  • Conduction blood/fluid warmer

BD Perisafe - 00382904002732

KIT PERISAFE 18GA 3-1/2IN WEISS
BECTON, DICKINSON AND COMPANY
400273
In Commercial Distribution

  • 50382904002737 ()
  • 00382904002732 ()
  • 30382904002733 ()

  • Needle Gauge: 18 Gauge
  • Length: 3.5 Inch
400273

  • Intrathecal anaesthesia set, non-medicated

SIGMA Spectrum Infusion Pump - 00085412498683

The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library provides delivery of fluids in a controlled manner. It is a software controlled electromechanical device used for infusion of pharmaceutical drugs, blood, blood products and mixtures of patient therapy through administration sets.
BAXTER INTERNATIONAL INC.
35700BAX2
In Commercial Distribution

  • 00085412498683 ()
35700BAX2

  • Bedside infusion pump, single-channel

MSI Precision Specialty Instruments - 00194613099176

Tebbetts Stainless Steel Fiber Optic Retractor, With Comfort Grip 150mm x 36mm Blade With Teeth To Help With Tissue Slippage With Smoke Evacuation Suction Tube And With Replaceable Fiber Optic Design
Med Saver, Inc.
220-2080-150T
In Commercial Distribution

  • 00194613099176 ()


  • Fibreoptic retractor handle

MSI Precision Specialty Instruments - 00194613099121

Tebbetts Stainless Steel Fiber Optic Retractor, With Comfort Grip 80mm x 16mm Blade With Teeth To Help With Tissue Slippage With Smoke Evacuation Suction Tube And With Replaceable Fiber Optic Design
Med Saver, Inc.
220-2080-08016T
In Commercial Distribution

  • 00194613099121 ()


  • Fibreoptic retractor handle

Maquira - 07898938244732

The Odontological Aspirator with Bone Collector offers greater safety in procedures, reducing the chances of contamination of both the professional and his patients.
Maquira Industria de Produtos Odontologicos S/A
Box with 10 sterilized Odontological Aspirator with Bone Collector
In Commercial Distribution

  • 07898938244732 ()
80322409003

  • Dental suction system cannula, single-use

VersaCross Steerable Sheath - 00685447005537

1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71L-D1
Not in Commercial Distribution

  • 00685447005537 ()

  • 72cm 8.5F VersaCross Steerable Sheath with large curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with large curve


  • Cardiac transseptal access set

VersaCross Steerable Sheath - 00685447005520

1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71L-D0
Not in Commercial Distribution

  • 00685447005520 ()

  • 72cm 8.5F VersaCross Steerable Sheath with large curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with standard curve


  • Cardiac transseptal access set

VersaCross Steerable Sheath - 00685447005513

1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71M-D1
Not in Commercial Distribution

  • 00685447005513 ()

  • 72cm 8.5F VersaCross Steerable Sheath with medium curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with large curve


  • Cardiac transseptal access set

VersaCross Steerable Sheath - 00685447005506

1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71M-D0
Not in Commercial Distribution

  • 00685447005506 ()

  • 72cm 8.5F VersaCross Steerable Sheath with medium curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with standard curve


  • Cardiac transseptal access set

VersaCross Steerable Sheath - 00685447005490

1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71S-D1
Not in Commercial Distribution

  • 00685447005490 ()

  • 72cm 8.5F VersaCross Steerable Sheath with small curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with large curve


  • Cardiac transseptal access set

VersaCross Steerable Sheath - 00685447005483

1 x VersaCross Steerable Sheath (including 1 x J-Tip Guidewire); 1 x VersaCross Transseptal Dilator
Baylis Médicale Cie Inc
VST85-35-BD-71S-D0
Not in Commercial Distribution

  • 00685447005483 ()

  • 72cm 8.5F VersaCross Steerable Sheath with small curve (including 180cm J-Tip Guidewire with OD = 0.035 inch); 8.5F 95cm VersaCross Transseptal Dilator with standard curve


  • Cardiac transseptal access set

VersaCross Transseptal Sheath - 00685447003526

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-37-D1
Not in Commercial Distribution

  • 00685447003526 ()

  • 63cm 8F VersaCross Transseptal Sheath with 37° curve; 67cm 8F VersaCross Transseptal Dilator with Large Curve D1; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003519

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-135-D0
Not in Commercial Distribution

  • 00685447003519 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 135° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003502

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-90-D0
Not in Commercial Distribution

  • 00685447003502 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 90° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003496

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-55-D0
Not in Commercial Distribution

  • 00685447003496 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 55° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003489

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-45-D0
In Commercial Distribution

  • 00685447003489 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 45° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003472

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-81-37-D0
Not in Commercial Distribution

  • 00685447003472 ()

  • 81cm 8.5F VersaCross Transseptal Sheath with 37° curve; 85cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003465

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-135-D0
Not in Commercial Distribution

  • 00685447003465 ()

  • 81cm 8F VersaCross Transseptal Sheath with 135° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003458

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-90-D0
Not in Commercial Distribution

  • 00685447003458 ()

  • 81cm 8F VersaCross Transseptal Sheath with 90° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003441

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-55-D0
Not in Commercial Distribution

  • 00685447003441 ()

  • 81cm 8F VersaCross Transseptal Sheath with 55° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003434

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-45-D0
Not in Commercial Distribution

  • 00685447003434 ()

  • 81cm 8F VersaCross Transseptal Sheath with 45° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003427

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-81-37-D0
Not in Commercial Distribution

  • 00685447003427 ()

  • 81cm 8F VersaCross Transseptal Sheath with 37° curve; 85cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003410

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-135-D0
Not in Commercial Distribution

  • 00685447003410 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 135° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003403

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-90-D0
In Commercial Distribution

  • 00685447003403 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 90° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003397

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-55-D0
In Commercial Distribution

  • 00685447003397 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 55° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003380

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-45-D0
In Commercial Distribution

  • 00685447003380 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 45° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003373

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS85-35-63-37-D0
Not in Commercial Distribution

  • 00685447003373 ()

  • 63cm 8.5F VersaCross Transseptal Sheath with 37° curve; 67cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003366

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-135-D0
Not in Commercial Distribution

  • 00685447003366 ()

  • 63cm 8F VersaCross Transseptal Sheath with 135° curve; 67cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003359

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-90-D0
Not in Commercial Distribution

  • 00685447003359 ()

  • 63cm 8F VersaCross Transseptal Sheath with 90° curve; 67cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003342

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-55-D0
Not in Commercial Distribution

  • 00685447003342 ()

  • 63cm 8F VersaCross Transseptal Sheath with 55° curve; 67cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003335

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-45-D0
Not in Commercial Distribution

  • 00685447003335 ()

  • 63cm 8F VersaCross Transseptal Sheath with 45° curve; 67cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use

VersaCross Transseptal Sheath - 00685447003328

1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
Baylis Médicale Cie Inc
VXS8-35-63-37-D0
Not in Commercial Distribution

  • 00685447003328 ()

  • 63cm 8F VersaCross Transseptal Sheath with 37° curve; 67cm 8F VersaCross Transseptal Dilator with Standard Curve D0; 180cm J-Tip Guidewire with OD = 0.035 inch


  • Vascular guide-catheter, single-use
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