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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The air sensor is a non-invasive, ultrasonic sensor that can detect air bubbles in the perfusion circuit. This is the 3/8"x3/32" sensor. Includes cable and holder.
Terumo Cardiovascular Systems Corporation
5773
In Commercial Distribution

  • 00886799000038 ()
5773

  • Cardiopulmonary bypass system air bubble/fluid level detector
No Description
LivaNova Deutschland GmbH
Pads Green
In Commercial Distribution

  • 34033817900635 ()
  • 04033817900634 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Pads White
In Commercial Distribution

  • 34033817900628 ()
  • 04033817900627 ()


  • Cardiopulmonary bypass system, roller type
No Description
Maquet Cardiopulmonary AG
Extended Mast System
In Commercial Distribution

  • 04037691762326 ()
701043271

  • Cardiopulmonary bypass system, roller type
CARDIOHELP Holder for mast
Maquet Cardiopulmonary AG
CARDIOHELP Holder for mast HKH 9102-M
In Commercial Distribution

  • 04037691720791 ()
70104.9584

  • Medical device rail
Gas bottle holder for helicopter.
Maquet Cardiopulmonary AG
Gas bottle holder f. helicopter HKH 8880
Not in Commercial Distribution

  • 04037691718330 ()
70105.0901

  • Medical device rail
CARDIOHELP-i mobile holder. The CARDIOHELP-i Mobile Holder is for connection to the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP mobile holder CARDIOHELP protection cover
Maquet Cardiopulmonary AG
Cardiohelp Mobile Holder HKH 8860
Not in Commercial Distribution

  • 04037691717968 ()
70105.0897

  • Medical device rail
Level Sensor Pads LSP 20-531, non-sterile, box of 100 pieces
Maquet Cardiopulmonary AG
LSP 20-531
In Commercial Distribution

  • 04037691687308 ()
701022208

  • Cardiopulmonary bypass system, roller type
The CLS is a device to monitor blood or saline level in a reservoir and to generate an electrical signal if the level falls below a predetermined value.
Maquet Cardiopulmonary AG
CLS L2.0
In Commercial Distribution

  • 04037691682907 ()
70104.9252

  • Cardiopulmonary bypass system air bubble/fluid level detector
No Description
Maquet Cardiopulmonary AG
Mast adapter D30 H45
In Commercial Distribution

  • 04037691682549 ()
701051531

  • Cardiopulmonary bypass system, roller type
CARDIOHELP Emergency Drive Holder for mast
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive Holder, Mast
In Commercial Distribution

  • 04037691645155 ()
70104.8006

  • Medical device rail
CARDIOHELP Emergency Drive Holder for rail
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive holder, Rail
In Commercial Distribution

  • 04037691645148 ()
70104.9304

  • Medical device rail
CARDIOHELP Emergency Drive
Maquet Cardiopulmonary AG
CARDIOHELP Emergency Drive (w/o holder)
Not in Commercial Distribution

  • 04037691643526 ()
70104.8002

  • Cardiopulmonary bypass system, roller type
The Venous Probe is to measure SO2, Hb, HCT and venous temperature as an accessory for CARDIOHELP. The CARDIOHELP System is a miniaturized and light medical perfusion system. The general function of the CARDIOHELP System is to drive, to control, to monitor and to protocol the extra corporeal circulation (ECC). The CARDIOHELP System acts as a drive unit for a disposable tubing set including at least pump and oxygenator.
Maquet Cardiopulmonary AG
Venous Probe
In Commercial Distribution

  • 04037691641041 ()

  • Weight: 0.208 Kilogram
  • Total Volume: 2.569 Liter
70104.8803

  • Extracorporeal blood gas/pH monitor
No Description
Maquet Cardiopulmonary AG
Side guard
In Commercial Distribution

  • 04037691585598 ()
701043272

  • Cardiopulmonary bypass system, roller type
The STI 1/2" x 1/16" (4 pcs) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.
Maquet Cardiopulmonary AG
STI 1/2" x 1/16" (4 pcs)
In Commercial Distribution

  • 04037691477251 ()

  • Weight: 0.16 Kilogram
701020800

  • Cardiopulmonary bypass system, roller type
The STI 1/4" x 1/16" (4 pcs.) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.
Maquet Cardiopulmonary AG
STI 1/4" x 1/16" (4 pcs)
In Commercial Distribution

  • 04037691477206 ()

  • Weight: 0.02 Kilogram
701020798

  • Cardiopulmonary bypass system, roller type
No Description
Maquet Cardiopulmonary AG
Complete Holder 200mm Arm
In Commercial Distribution

  • 04037691457659 ()
701045168

  • Cardiopulmonary bypass system, roller type
Wall holder for ambulance. Mandatory for ambulance transportation.
Maquet Cardiopulmonary AG
Wall holder HKH 8820
Not in Commercial Distribution

  • 04037691456584 ()
70104.5366

  • Medical device rail
CONSOLE R5100052 PERFORMER CPB,UNIV
MEDTRONIC, INC.
R5100052
In Commercial Distribution

  • 00885074514857 ()


  • Cardiopulmonary bypass system, roller type
Phonak Charger Case Combi incl. EU EPS
Sonova AG
075-0040-12
In Commercial Distribution

  • 07613389177824 ()


  • Noninvasive device battery charger
Easy Line Charger RIC 2 US EPS
Sonova AG
075-5871-11
In Commercial Distribution

  • 07613389558616 ()
075-5871-11

  • Noninvasive device battery charger
Unitron Charger Combi BTE incl. EU EPS
Sonova AG
075-5869-12
In Commercial Distribution

  • 07613389551044 ()


  • Noninvasive device battery charger
Unitron Charger Combi BTE incl. US EPS
Sonova AG
075-5869-11
In Commercial Distribution

  • 07613389551037 ()


  • Noninvasive device battery charger
Easy Line Charger Combi BTE no EPS
Sonova AG
075-5865-10
In Commercial Distribution

  • 07613389537413 ()


  • Noninvasive device battery charger
Phonak Charger Combi BTE incl. EU EPS
Sonova AG
075-0062-12
In Commercial Distribution

  • 07613389532548 ()


  • Air-conduction hearing aid, receiver-in-canal
Phonak Charger Combi BTE incl. US EPS
Sonova AG
075-0062-11
In Commercial Distribution

  • 07613389532531 ()


  • Air-conduction hearing aid, receiver-in-canal
Kirkland Signature 11.0 T Charger US EPS
Sonova AG
075-0051-11
In Commercial Distribution

  • 07613389513790 ()


  • Noninvasive device battery charger
Kirkland Signature 11.0 T Charger NO EPS
Sonova AG
075-0051-10
In Commercial Distribution

  • 07613389513783 ()


  • Noninvasive device battery charger
Phonak Charger Case Combi incl. UK EPS
Sonova AG
075-0040-13
In Commercial Distribution

  • 07613389478969 ()
075-0040-13

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. JP EPS
Sonova AG
075-0040-16
In Commercial Distribution

  • 07613389478952 ()
075-0040-16

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. IN EPS
Sonova AG
075-0040-18
In Commercial Distribution

  • 07613389478945 ()
075-0040-18

  • Noninvasive device battery charger
Phonak Charger Case Combi incl. KO EPS
Sonova AG
075-0040-17
In Commercial Distribution

  • 07613389446579 ()
075-0040-17

  • Noninvasive device battery charger
Phonak charger combi BTE 2 no EPS
Sonova AG
075-0065-10
In Commercial Distribution

  • 07613389629538 ()


  • Noninvasive device battery charger
Kirkland Signature Charger Case 2 US EPS
Sonova AG
075-0064-11
In Commercial Distribution

  • 07613389629507 ()


  • Noninvasive device battery charger
Kirkland Signature Charger Case 2 no EPS
Sonova AG
075-0064-10
In Commercial Distribution

  • 07613389629491 ()


  • Noninvasive device battery charger
Phonak charger case combi 2 no EPS
Sonova AG
075-0063
In Commercial Distribution

  • 07613389629439 ()


  • Noninvasive device battery charger
Unitron Charger Moxi R incl. US EPS
Unitron Hearing Division
075-5846-11
In Commercial Distribution

  • 07613389386851 ()
075-5846-11

  • Noninvasive device battery charger
Instrument Kit for EPS Plate, Long Screws
GRAMERCY EXTREMITY ORTHOPEDICS LLC
70120002
In Commercial Distribution

  • B471701200020 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
Plate Screw Non-Locking 3.5mm x 60mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023560
In Commercial Distribution

  • B471110235600 ()

  • Length: 60 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Plate Screw Non-Locking 3.5mm x 55mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023555
In Commercial Distribution

  • B471110235550 ()

  • Length: 55 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Plate Screw Non-Locking 3.5mm x 50mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023550
In Commercial Distribution

  • B471110235500 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 50 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Plate Screw Non-Locking 3.5mm x 48mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023548
In Commercial Distribution

  • B471110235480 ()

  • Length: 48 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Plate Screw Non-Locking 3.5mm x 46mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023546
In Commercial Distribution

  • B471110235460 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 46 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Plate Screw Non-Locking 3.5mm x 44mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023544
In Commercial Distribution

  • B471110235440 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 44 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
Plate Screw Non-Locking 3.5mm x 42mm, EPS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
11023542
In Commercial Distribution

  • B471110235420 ()

  • Length: 42 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Roche Diagnostics GmbH
08056820190
In Commercial Distribution

  • 07613336121016 ()
08056820190

  • Amylase isoenzyme IVD, kit, spectrophotometry
Plate Bender (2) Pack 1.5mm
GRAMERCY EXTREMITY ORTHOPEDICS LLC
71240001
In Commercial Distribution

  • B471712400010 ()


  • Manual orthopaedic bender, single-use
Cannulated Drill, AO, 1.9mm x 135mm
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21119135
In Commercial Distribution

  • B471211191350 ()


  • Cannulated surgical drill bit, single-use
Driver Tip Hexalobe T-15 Solid 100mm
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20019915
In Commercial Distribution

  • B471200199150 ()


  • Surgical screwdriver, single-use
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