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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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ID NOW™ COVID-19 - 10811877011269

A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
190-000
Not in Commercial Distribution

  • 10811877011269 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Flexiva™ ID TracTip - 08714729963837

High Power Single-Use Laser Fiber
BOSTON SCIENTIFIC CORPORATION
M006R8403960
Not in Commercial Distribution

  • 08714729963844 ()
  • 08714729963837 ()

  • 242 um Diameter


  • General/multiple surgical laser system beam guide, single-use

CaStar Cap, 22mm ID - 08058323016606

No Description
Intersurgical Incorporated
STR/019
In Commercial Distribution

  • 08058323030831 ()
  • 08058323016606 ()


  • Straight/elbow breathing circuit connector, single-use

RAPID ID 32 E - 03573026588649

rapid ID 32 E is a standardized system for the identification of Enterobacteriaceae in 4 hours
BIOMERIEUX SA
RAPID ID 32 E
In Commercial Distribution

  • 03573026066574 ()
  • 03573026588649 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit

RAPID ID 32 STREP - 03573026588625

rapid ID 32 STREP is a standardized system for the identification of streptococci and enterococci, and those most common related organisms, in 4 hours
BIOMERIEUX SA
RAPID ID 32 STREP
In Commercial Distribution

  • 03573026066536 ()
  • 03573026588625 ()


  • Multiple Streptococcus bacterial species culture isolate identification IVD, kit

RAPID ID 32 A - 03573026588564

rapid ID 32 A is a standardized system for the identification of anaerobes in 4 hours
BIOMERIEUX SA
RAPID ID 32 A
In Commercial Distribution

  • 03573026066420 ()
  • 03573026588564 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, kit

ID NOW COVID-19 2.0 - 00811877011354

A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.
Alere Scarborough, Inc.
192-000
In Commercial Distribution

  • 00811877011354 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

ID NOW™ Instrument - 00811877010616

The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200XS
In Commercial Distribution

  • 00811877010616 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory

ID NOW™ Instrument - 00811877010593

The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200X
In Commercial Distribution

  • 00811877010593 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory

Gas ID Label Strips - 00813830020106

No Description
ACCUTRON, INC.
23126
Not in Commercial Distribution

  • 00813830020106 ()
23126

  • Medical gas pipeline system

ID Breathing Bag Set - 04048675250241

No Description
Drägerwerk AG & Co. KGaA
MP00341
In Commercial Distribution

  • 04048675250241 ()
  • 04048675422136 ()


  • Anaesthesia breathing circuit, single-use

ID Circuit Basic 250 - 04048675249344

No Description
Drägerwerk AG & Co. KGaA
MP01348
In Commercial Distribution

  • 04048675249344 ()
  • 04048675421443 ()


  • Ventilator breathing circuit, single-use

ID Circuit Flex 220 - 04048675249337

No Description
Drägerwerk AG & Co. KGaA
MP01347
In Commercial Distribution

  • 04048675249337 ()
  • 04048675421450 ()


  • Ventilator breathing circuit, single-use

ID Bag Set 150 - 04048675248521

No Description
Drägerwerk AG & Co. KGaA
MP01330
In Commercial Distribution

  • 04048675248521 ()
  • 04048675421498 ()


  • Anaesthesia breathing circuit, single-use

ID Circuit Watertrap 180 - 04048675248514

No Description
Drägerwerk AG & Co. KGaA
MP01326
In Commercial Distribution

  • 04048675248514 ()
  • 04048675421535 ()


  • Ventilator breathing circuit, single-use

ID Breath.circuit smoothbore 3 - 04048675248507

No Description
Drägerwerk AG & Co. KGaA
MP01325
Not in Commercial Distribution

  • 04048675248507 ()
  • 04048675421542 ()


  • Ventilator breathing circuit, single-use

Infinity ID Flow Sensor - 04048675448938

No Description
Drägerwerk AG & Co. KGaA
6871980
In Commercial Distribution

  • 04048675448938 ()


  • Breathing circuit gas-flow sensor, reusable

ID Circuit Basic 180 - 04048675250609

No Description
Drägerwerk AG & Co. KGaA
MP01350
In Commercial Distribution

  • 04048675250609 ()
  • 04048675421436 ()


  • Ventilator breathing circuit, single-use

STRAIGHT CONNECTOR, DISPOSABLE (OD:12mm, ID:15mm) - 04716770144320

STRAIGHT CONNECTOR, DISPOSABLE (OD:12mm, ID:15mm)
BESMED HEALTH BUSINESS CORP.
CT-14432
In Commercial Distribution

  • 04716770144320 ()


  • Oxygen administration tubing

STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm,OD:6mm) - 04716770144047

STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm,OD:6mm)
BESMED HEALTH BUSINESS CORP.
CT-14404
In Commercial Distribution

  • 04716770144047 ()


  • Oxygen administration tubing

STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm,OD:15mm) - 04716770144009

STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm,OD:15mm)
BESMED HEALTH BUSINESS CORP.
CT-14400
In Commercial Distribution

  • 04716770144009 ()


  • Oxygen administration tubing

STRAIGHT CONNECTOR, DISPOSABLE (OD:15mm,ID:22mm) - 04716770143088

STRAIGHT CONNECTOR, DISPOSABLE (OD:15mm,ID:22mm)
BESMED HEALTH BUSINESS CORP.
CT-14308
In Commercial Distribution

  • 04716770143088 ()


  • Oxygen administration tubing

STRAIGHT CONNECTOR,DISPOSABLE(OD:15mm,ID:22mm) - 04716770141046

STRAIGHT CONNECTOR,DISPOSABLE(OD:15mm,ID:22mm)
BESMED HEALTH BUSINESS CORP.
CT-14104
In Commercial Distribution

  • 04716770141046 ()


  • Oxygen administration tubing

STRAIGHT CONNECTOR,DISPOSABLE(OD:22mm,ID:22mm) - 04716770141039

STRAIGHT CONNECTOR,DISPOSABLE(OD:22mm,ID:22mm)
BESMED HEALTH BUSINESS CORP.
CT-14103
In Commercial Distribution

  • 04716770141039 ()


  • Oxygen administration tubing

T PIECE (OD:22mm;ID:22mm)/TRANSPARENT - 04716770131429

T PIECE (OD:22mm;ID:22mm)/TRANSPARENT
BESMED HEALTH BUSINESS CORP.
CT-13142
In Commercial Distribution

  • 04716770131429 ()


  • Oxygen administration tubing

Rocket - 05055270909060

Rocket Silicone Tubing 5mm ID 2 metres
ROCKET MEDICAL PLC
R28135
Not in Commercial Distribution

  • 05055270909060 ()
R28135

  • Closed-wound drain, non-bioabsorbable

Adscope® - 00634782061722

Scope ID Tag, Premium,Black, Disp pkg
AMERICAN DIAGNOSTIC CORP
697BKQ
In Commercial Distribution

  • 00634782561529 ()
  • 00634782061722 ()
  • 00634782024529 ()
697BKQ

  • Mechanical external stethoscope

Proscope™ - 00634782057671

Scope ID Tag, Economy,Black, Disp Pkg
AMERICAN DIAGNOSTIC CORP
698BKQ
In Commercial Distribution

  • 00634782557454 ()
  • 00634782057671 ()
  • 00634782024529 ()
698BKQ

  • Mechanical external stethoscope

Adscope® - 00634782083786

Scope ID Tag, Premium,Breast Cancer Awareness
AMERICAN DIAGNOSTIC CORP
697BCA
In Commercial Distribution

  • 00634782885182 ()
  • 00634782083786 ()
697BCA

  • Mechanical external stethoscope

HCS - 00849027003805

Patient ID Band, Yellow "Fall Risk” Alert
DYAD MEDICAL SOURCING, LLC
HCS1320Y
In Commercial Distribution

  • 10849027003802 ()
  • 00849027003805 ()
  • 20849027003809 ()


  • Patient identification band
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