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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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BagEasy - 00709078008061

BagEasy, Adult Resuscitator, W/Mask (Uncollapsed)
WESTMED, INC.
562201
In Commercial Distribution

  • 10709078008068 ()
  • 00709078008061 ()


  • Pulmonary resuscitator, manual, single-use

Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) - 00868058000416

The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard blood tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors (thermal resistors) located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.
NORTH AMERICAN RESCUE, LLC
63-5904
In Commercial Distribution

  • 00868058000454 ()
  • 00868058000416 ()
35-0005

  • Conduction blood/fluid warmer set

KENOREX - 00866512000224

PULMONARY RESUSCITATOR, MANUAL FOR INFANTS
KENTRON HEALTHCARE, INC.
779502
In Commercial Distribution

  • 00866512000224 ()
  • 10866512000221 ()
779502

  • Pulmonary resuscitator, manual, single-use

KENOREX - 00866512000217

PULMONARY RESUSCITATOR, MANUAL FOR CHILDREN
KENTRON HEALTHCARE, INC.
779501
In Commercial Distribution

  • 00866512000217 ()
  • 10866512000214 ()
779501

  • Pulmonary resuscitator, manual, single-use

KENOREX - 00866512000200

PULMONARY RESUSCITATOR, MANUAL
KENTRON HEALTHCARE, INC.
779500
In Commercial Distribution

  • 00866512000200 ()
  • 10866512000207 ()
779500

  • Pulmonary resuscitator, manual, single-use

Elevess - 00866142000014

Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel
Anika Therapeutics, Inc.
685-310
Not in Commercial Distribution

  • 00866142000014 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Hydrelle - 00866142000007

Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel
Anika Therapeutics, Inc.
685-015
In Commercial Distribution

  • 00866142000007 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

Chinook BVM Module - 00856767008052

No Description
Altitude Technologies Inc.
1373
In Commercial Distribution

  • 00856767008052 ()


  • Pulmonary resuscitator, manual, single-use

SIGNIA - 05714880142587

KIT STYLETTO 3AX EU SNW RGD
Ws Audiology Usa, Inc.
KIT Styletto 3AX
In Commercial Distribution

  • 05714880142587 ()
21003668

  • Convection blood/fluid warmer set

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480110469

SPUR II Ped Bag Res, Tod FM, Mano, Disp PEEP, 10' Ox Tube
Ambu A/S
530613047
Not in Commercial Distribution

  • 05707480110469 ()
  • 05707480110476 ()

  • Pediatric
530613047

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - 05707480110445

SPUR II Inf Bag Res, Neon & Inf FM, Mano, Disp PEEP, 10' Ox
Ambu A/S
540216047
Not in Commercial Distribution

  • 05707480110445 ()
  • 05707480110452 ()

  • Infant
540216047

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480110407

SPUR II Ped, Tube Res, Tod FM, Mano, 10' Oxygen Supply Tube
Ambu A/S
531613016
In Commercial Distribution

  • 05707480110407 ()
  • 05707480110414 ()

  • Pediatric
531613016

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480109937

SPUR II Ped Bag Res Peep, Mano
Ambu A/S
530619031
In Commercial Distribution

  • 05707480109937 ()
  • 05707480109944 ()

  • Pediatric
530619031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - 05707480109913

SPUR II Inf, Tube Resv, Peep & Mano attached
Ambu A/S
544200031
In Commercial Distribution

  • 05707480109913 ()
  • 05707480109920 ()

  • Infant
544200031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator - 05707480109838

SPUR II Adult, Bag Res, Md & Lg Ad FM
Ambu A/S
520214000
In Commercial Distribution

  • 05707480109838 ()
  • 05707480109845 ()

  • Adult
520214000

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric Resuscitatorwith Filter - 05707480109814

SPUR II Ped, Tube Resv, Tod FM, Mercury Filter, Manometer
Ambu A/S
531613017
In Commercial Distribution

  • 05707480109814 ()
  • 05707480109821 ()

  • Pediatric
531613017

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult Resuscitatorw/Nellcor CO2 Detector - 05707480109555

SPUR II Adult, Med Adlt FM, Nellcor EasyCap, Disp Peep, 6/cs
Ambu A/S
520611701N
In Commercial Distribution

  • 05707480109555 ()
  • 05707480109562 ()

  • Adult
520611701N

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric Resuscitatorw/Nellcor CO2 Detector - 05707480109531

SPUR II Ped, Todd FM, Nellcor Ped Cap, Disp Peep, 6/cs
Ambu A/S
530613801N
Not in Commercial Distribution

  • 05707480109531 ()
  • 05707480109548 ()

  • Pediatric
530613801N

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult Resuscitatorw/Expiratory Filter - 05707480109517

SPUR II Adult Med Adt FM 14 Ox Tube Mercury Filt 6 cs
Ambu A/S
520611066
In Commercial Distribution

  • 05707480109517 ()
  • 05707480109524 ()

  • Adult
520611066

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant Resuscitatorw/Inspiratory Filter - 05707480107254

INFANT FACE MASK, INSPIRATORY FILTER
Ambu A/S
544212033
In Commercial Distribution

  • 05707480107254 ()
  • 05707480107261 ()

  • Infant
544212033

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - 05707480107216

NEO & INF FM, DISP MANO, 10" OX SUPPLY TUBING, 43 MM BERMAN
Ambu A/S
544216069
In Commercial Distribution

  • 05707480107216 ()
  • 05707480107223 ()

  • Infant
544216069

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator - 05707480107193

ADULT FACE MASK, DISP PEEP, 10 OX SUPPLY TUBING
Ambu A/S
521611011
In Commercial Distribution

  • 05707480107193 ()
  • 05707480107209 ()

  • Adult
521611011

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480106356

Spur II Ped, Bag Resv
Ambu A/S
530635031
In Commercial Distribution

  • 05707480106356 ()
  • 05707480106349 ()

  • Pediatric
530635031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - 05707480106325

SPUR II Inf. Tube Resv
Ambu A/S
544236031
In Commercial Distribution

  • 05707480106325 ()
  • 05707480106332 ()

  • Infant
544236031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480106301

Spur II Ped, Bag Resv
Ambu A/S
530613071
In Commercial Distribution

  • 05707480106301 ()
  • 05707480106318 ()

  • Pediatric
530613071

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator - 05707480106288

Spur II Adlt, Bag Resv, Med Adult F M without wrapping, Peep
Ambu A/S
520211071
In Commercial Distribution

  • 05707480106288 ()
  • 05707480106295 ()

  • Adult
520211071

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480105908

SPUR II Pediatric, F M, Disp PEEP Valve, 10' CO2 Supply Tub
Ambu A/S
530613011
In Commercial Distribution

  • 05707480105908 ()
  • 05707480105915 ()

  • Pediatric
530613011

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult Resuscitatorw / Pressure Limiting Valve - 05707480105885

SPUR II Adult Tube Resuscitator
Ambu A/S
524611047
In Commercial Distribution

  • 05707480105885 ()
  • 05707480105892 ()

  • Adult
524611047

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult Resuscitatorw / Pressure Limiting Valve - 05707480105823

SPUR II ADLT TUBE RESVR. Pressure.
Ambu A/S
524611031
In Commercial Distribution

  • 05707480105823 ()
  • 05707480105830 ()

  • Adult
524611031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - 05707480105342

SPUR II Infant Bag Resuscitator
Ambu A/S
540200031
In Commercial Distribution

  • 05707480105342 ()
  • 05707480105359 ()

  • Infant
540200031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480105328

Inf &Todd Face Mask, Disp Manometer, Disp PEEP Valve 12/cs
Ambu A/S
530215031
In Commercial Distribution

  • 05707480105328 ()
  • 05707480105335 ()

  • Pediatric
530215031

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator - 05707480105304

Infant Face Mask, Mercury Exhalation Filter, Manometer 12/cs
Ambu A/S
544212017
In Commercial Distribution

  • 05707480105304 ()
  • 05707480105311 ()

  • Infant
544212017

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorMASK.INF.W/10' O2 & MANOMETER - 05707480103621

MaSK.INF.W/10" O2 & MANOMETER
Ambu A/S
544212016
In Commercial Distribution

  • 05707480103621 ()
  • 05707480102426 ()

  • Infant
544212016

  • Pulmonary resuscitator, manual, single-use

SPUR® II Infant ResuscitatorNo Mask, with Manometer - 05707480103614

NO MASK W/MANOMETER CS/12
Ambu A/S
540200030
In Commercial Distribution

  • 05707480103614 ()
  • 05707480102419 ()

  • Infant
540200030

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorINF&TOD W/MANOMETER - 05707480103607

INF&TOD W/MANOMETER CS/6
Ambu A/S
530615030
In Commercial Distribution

  • 05707480103607 ()
  • 05707480047581 ()

  • Pediatric
530615030

  • Pulmonary resuscitator, manual, single-use

SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator - 05707480103584

02 TUBE,SM.ADLT.PP.MAN
Ambu A/S
530218047
In Commercial Distribution

  • 05707480103584 ()
  • 05707480047383 ()

  • Pediatric
530218047

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator - 05707480103560

SPUR II Adult Bag Resuscitator
Ambu A/S
523632016
In Commercial Distribution

  • 05707480103560 ()
  • 05707480047222 ()

  • Adult
523632016

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult Resuscitatorw/CO2 Detector - 05707480103553

MSK, MED.ADLT,AD CO2 DET
Ambu A/S
523611700
In Commercial Distribution

  • 05707480103553 ()
  • 05707480102389 ()

  • Adult
523611700

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult Resuscitator40"TUBE RESV., MSK NO WRAP,PEEP - 05707480103546

MED ADLT NO WRAP,PEEP
Ambu A/S
521611067
Not in Commercial Distribution

  • 05707480103546 ()
  • 05707480102372 ()

  • Adult
521611067

  • Pulmonary resuscitator, manual, single-use

SPUR® II Adult ResuscitatorMask Md. Adult, Exhalation Filter - 05707480103522

MSK, MD ADLT, 30MM VL V
Ambu A/S
520611048
In Commercial Distribution

  • 05707480103522 ()
  • 05707480102358 ()

  • Adult
520611048

  • Pulmonary resuscitator, manual, single-use
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