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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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Molded Products, Inc. - B144MPC1300

See Luer Cap Set
MOLDED PRODUCTS, INC.
MPC-130
In Commercial Distribution

  • B144MPC1301 ()
  • B144MPC1300 ()
  • B144MPC1303 ()
MPC-130

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1240

Luer Lock Cap Set - (1) Red and (1) Blue per Set
MOLDED PRODUCTS, INC.
MPC-124
In Commercial Distribution

  • B144MPC1241 ()
  • B144MPC1240 ()
  • B144MPC1242 ()
MPC-124

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1100

NeedleFree Injection Site
MOLDED PRODUCTS, INC.
MPC-110
In Commercial Distribution

  • B144MPC1101 ()
  • B144MPC1100 ()
  • B144MPC1104 ()
MPC-110

  • Catheter injection port

Premium Study Kit - B14360201261

Single use, premium study kit with two XXlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XXLarge
In Commercial Distribution

  • B14360201282 ()
  • B14360201261 ()
  • B14360201272 ()
602-0123

  • Electroencephalograph

Premium Study Kit - B14360201231

Single use, premium study kit with two Xlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XLarge
In Commercial Distribution

  • B14360201252 ()
  • B14360201231 ()
  • B14360201242 ()
602-0123

  • Electroencephalograph

Premium Study Kit - B14360201201

Single use, premium study kit with two large ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - Large
In Commercial Distribution

  • B14360201222 ()
  • B14360201201 ()
  • B14360201212 ()
602-0120

  • Electroencephalograph

Premium Study Kit - B14360201141

Single use, premium study kit extra extra large.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B14360201141 ()
  • B14360201162 ()
  • B14360201152 ()
602-0114

  • Electroencephalograph

Premium Study Kit - B14360201111

Single use, premium study kit extra large.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B14360201111 ()
  • B14360201132 ()
  • B14360201122 ()
602-0111

  • Electroencephalograph

Premium Study Kit - B14360201081

Single use, premium study kit large.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B14360201081 ()
  • B14360201102 ()
  • B14360201092 ()
602-0108

  • Electroencephalograph

Premium Study Kit - B14360200791

Single use, proact premium study kit.
Cleveland Medical Devices Inc.
Proact - Single
In Commercial Distribution

  • B14360200791 ()
  • B14360200812 ()
  • B14360200802 ()
602-0079

  • Electroencephalograph

Study Kit - B14360200761

Single use study kit (compatible with thermistor).
Cleveland Medical Devices Inc.
Compatible with Thermistor - Single
In Commercial Distribution

  • B14360200761 ()
  • B14360200772 ()
  • B14360200782 ()
602-0076

  • Electroencephalograph

Study Kit - B14360200751

No Description
Cleveland Medical Devices Inc.
Single
In Commercial Distribution

  • B14360200751 ()
  • B14360200692 ()
  • B14360200682 ()
602-0075

  • Electroencephalograph

ReadyRip Belt - B143502020450

Single use, extra extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B143502020450 ()
  • B14360201051 ()
  • B14360201021 ()
502-0204-5

  • Electroencephalograph

ReadyRip Belt - B143502020440

Single use, extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B143502020440 ()
  • B14360201041 ()
  • B14360201011 ()
502-0204-4

  • Electroencephalograph

ReadyRip Belt - B143502020430

Single use, large respiratory belt.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B143502020430 ()
  • B14360201031 ()
  • B14360201001 ()
502-0204-3

  • Electroencephalograph

ReadyRip Belt - B143502020420

Single use, medium respiratory belt.
Cleveland Medical Devices Inc.
Medium - Single
In Commercial Distribution

  • B143502020420 ()
  • B14360201311 ()
  • B14360201301 ()
502-0204-2

  • Electroencephalograph

BRAEBON Q-RIP Belt, Pediatric - B1400572APED0

Pediatric belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0572APED
In Commercial Distribution

  • B1400572APED0 ()
  • B1400572APED1 ()
  • B1400572APED21 ()

  • Length: 24 Inch
0572APED

  • Pneumograph

CUVETTES DC-80 Box 100 cuvettes & 100 plugs - B154O00103910003

Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.
WATERS MEDICAL SYSTEMS, LLC
Cuvette/Plug Kit
In Commercial Distribution

  • B154O00103910003 ()
  • 0034791000 ()
  • 0033991000 ()
0010391.000

  • Intracardiac oximeter

CorVitals - B353CV12531

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
CV1253
In Commercial Distribution

  • B353CV12532 ()
  • B353CV12531 ()
  • B353CV12533 ()
CV1253_US

  • Electrocardiography telemetric monitoring system

CORVITALS - B353CV12451

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system

UbiqVue Multiparameter - B353UB25501

2A Wearable Biosensor
Lifesignals, Inc.
UB2550
In Commercial Distribution

  • B353UB25502 ()
  • B353UB25501 ()
  • B353UB25503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Holter - B353UB22511

2AYe Wearable Biosensor
Lifesignals, Inc.
UB2251
In Commercial Distribution

  • B353UB22512 ()
  • B353UB22511 ()
  • B353UB22513 ()


  • Electrocardiographic ambulatory recorder

UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, single-use

UbiqVue Holter - B353UB12511

1AXe Wearable Biosensor
Lifesignals, Inc.
UB1251
In Commercial Distribution

  • B353UB12512 ()
  • B353UB12511 ()
  • B353UB12513 ()


  • Electrocardiographic ambulatory recorder

MonitorMe - B353MM12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MM1250
Not in Commercial Distribution

  • B353MM12501 ()
  • B353MM12502 ()
  • B353MM12503 ()


  • Electrocardiography telemetric monitoring system

MAWI - B353MA12511

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12531

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1253
In Commercial Distribution

  • B353LP12532 ()
  • B353LP12531 ()
  • B353LP12533 ()
LP1253_US

  • Electrocardiography telemetric monitoring system

LifeSignals - B353LP12501

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
LP1250
Not in Commercial Distribution

  • B353LP12502 ()
  • B353LP12501 ()
  • B353LP12503 ()


  • Electrocardiographic ambulatory recorder

LifeSignal - B353LP11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
LP1110
Not in Commercial Distribution

  • B353LP11103 ()
  • B353LP11102 ()
  • B353LP11101 ()


  • Electrocardiography telemetric monitoring system

ImagineMed - B353IM12101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1210
Not in Commercial Distribution

  • B353IM12103 ()
  • B353IM12102 ()
  • B353IM12101 ()


  • Electrocardiography telemetric monitoring system

ImagineMIC - B353IM11101

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system

Cherish Serenity - B353CS124501

Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution

  • B353CS124502 ()
  • B353CS124501 ()
  • B353CS124503 ()


  • Electrocardiography telemetric monitoring system

Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

Clear Guide TipTAG - B201CGTT0

No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use

Clear Guide SteriMASK - B201CGSMM0

The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.
CLEAR GUIDE MEDICAL, INC.
CGSMM
In Commercial Distribution

  • B201CGSMM0 ()
  • B201CGSMM1 ()
  • B201CGSMM2 ()
CG-SM-M

  • Optical medical device procedural cover
  • Intraoperative ultrasound imaging transducer cover

Nasal Alar Sp02 Sensor - B2130201A010

The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor (REF 0201-A01) is for use with Philips FAST SpO2 compatible monitors.
XHALE ASSURANCE, INC.
0201-A01
In Commercial Distribution

  • B2130201A012 ()
  • B2130201A011 ()
  • B2130201A010 ()


  • Pulse oximeter probe, single-use

Nasal Alar Sp02 Sensor - B213301112140

The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
301-11214
In Commercial Distribution

  • B213301112140 ()
  • B213301112141 ()
  • B213301112142 ()


  • Pulse oximeter probe, single-use

Nasal Alar Sp02 Sensor - B21303030

The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
0303
In Commercial Distribution

  • B21303031 ()
  • B21303030 ()
  • B21303032 ()


  • Pulse oximeter probe, single-use

Easy Glide 60cc Luer Lock Syringe - B2086766600

Easy Glide 60cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
676660
In Commercial Distribution

  • B2086766600 ()
  • B2086766601 ()
  • B2086766603 ()


  • General-purpose syringe, single-use
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