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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 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

N/AN/A - 00884908104271

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 22GA NEEDLE22GA NEEDLE
Medical Components, Inc.
MR1903422
Not in Commercial Distribution

  • 30884908104272 ()
  • 00884908104271 ()
  • 50884908104276 ()
MR1903422

  • Vascular catheter introduction needle

N/AN/A - 00884908104233

3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA NEEDLE22GA NEEDLE
Medical Components, Inc.
MR1903222
Not in Commercial Distribution

  • 30884908104234 ()
  • 00884908104233 ()
  • 50884908104238 ()
MR1903222

  • Vascular catheter introduction needle

Extremity Care - 00850003042282

Cobra Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm
Extremity Care
ALC325
In Commercial Distribution

  • 00850003042282 ()

  • Outer Diameter: 3 Millimeter


  • Tissue injection cannula

Extremity Care - 00850003042275

Spatula Cannula Distal Tip for ID:2.5mm, OD:3.0mm, Spatula & Cobra Cannula Tube ID:2.5mm, OD:3.0mm
Extremity Care
ALC225
In Commercial Distribution

  • 00850003042275 ()

  • Outer Diameter: 3 Millimeter


  • Tissue injection cannula

Ontrak - 10841522129254

CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129254 ()

  • 32 cm-42 cm ID
016-0077-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129247

CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129247 ()

  • 12-20 cm/5-8in ID
015-0118-05Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129230

CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129230 ()

  • 24-32 cm/ 9-13 " ID
015-0068-06Q

  • Blood pressure ambulatory recorder
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