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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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This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies.
PASTURE PHARMA PTE LTD
A520G
In Commercial Distribution

  • B624A520G200 ()
  • B624A520G0 ()


  • Public respirator, single-use
SURG-BLADE SZ 22 STAINLES STEL
Cardinal Health 200, LLC
D2863-22
In Commercial Distribution

  • 50630140057517 ()
  • 20630140057516 ()
  • 10630140057519 ()
D2863-22

  • Manual scalpel blade, single-use
Sterile Surgical Blade Size 22
Cardinal Health 200, LLC
D2862-22A
In Commercial Distribution

  • 20885380103442 ()
  • 10885380103445 ()
  • 50885380103443 ()
D2862-22A

  • Manual scalpel blade, single-use
UNQ CABG PACK M 22
Cardinal Health 200, LLC
SCV23C1SEA
In Commercial Distribution

  • 50195594962737 ()
  • 10195594962739 ()
SCV23C1SEA

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
No Description
Drägerwerk AG & Co. KGaA
M25647
In Commercial Distribution

  • 04048675009238 ()


  • Neonatal/adult intensive-care ventilator
Malosa Core SMILE Pack 2-Beaver-Visitec International Ltd (30/SP)
Beaver-Visitec International, Inc.
MMK967
In Commercial Distribution

  • 05055186240066 ()
  • 35055186240661 ()
  • 30551862400664 ()
MMK967

  • Ophthalmic surgical procedure kit, non-medicated, single-use
No.7 Jewelers Ltd. Reuse.BP.Fcps. Curve Tip, Non Insulated
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
3909/7RBP
In Commercial Distribution

  • 00841645103448 ()


  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
N95 Health Care Particulate Respirator and Surgical Mask
BYD Precision Manufacture Co., Ltd.
DF1122
In Commercial Distribution

  • 00860003645154 ()

  • Circumference: 16.5 Inch
DF1122

  • Surgical/examination garment kit
Face Masks 100 Pack
VIVE HEALTH LLC
LVA2045
In Commercial Distribution

  • 10810041981759 ()
  • 00810041981752 ()


  • Scavenging anaesthesia face mask
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer
Abbott Diagnostics Technologies AS
1116986
In Commercial Distribution

  • 07070060014708 ()
1116986

  • Multiple clinical chemistry analyser IVD, point-of-care
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer
Abbott Diagnostics Technologies AS
1116985
In Commercial Distribution

  • 07070060014692 ()
1116985

  • Multiple clinical chemistry analyser IVD, point-of-care
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer
Abbott Diagnostics Technologies AS
1116971
In Commercial Distribution

  • 07070060014623 ()
1116971

  • Multiple clinical chemistry analyser IVD, point-of-care
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer
Abbott Diagnostics Technologies AS
1116970
In Commercial Distribution

  • 07070060014616 ()
1116970

  • Multiple clinical chemistry analyser IVD, point-of-care
Urine Collection Kit, ED, Health Care Worker, Columbus Medical Center Only
Aero-Med, Ltd.
CA16850
In Commercial Distribution

  • 50885380168817 ()
  • 10885380168819 ()
CA18650

  • Urine specimen collection kit IVD
Adult Female Blood Culture Collection Kit, Memorial Hermann Health System Only
Aero-Med, Ltd.
BCKF50B
In Commercial Distribution

  • 50885380167384 ()
  • 10885380167386 ()
BCKF50B

  • Phlebotomy kit
Adult Male Blood Culture Collection Kit, Memorial Hermann Health System Only
Aero-Med, Ltd.
BCKM50B
In Commercial Distribution

  • 50885380167087 ()
  • 10885380167089 ()
BCKM50B

  • Phlebotomy kit
UA and Culture Specimen Collection Kit, Henry Ford Health Systems Only
Aero-Med, Ltd.
CA11525
In Commercial Distribution

  • 50885380151475 ()
  • 10885380151477 ()
CA11525

  • Urine specimen collection kit IVD
Blood Culture Collection Kit, Steripath PIV Gen2, Adult, McLaren Health Only
Aero-Med, Ltd.
CA28275
Not in Commercial Distribution

  • 50885380175921 ()
  • 10885380175923 ()
CA28275

  • Phlebotomy kit
Blood Culture Collection Kit, Steripath 21G Gen2, Adult, McLaren Health Only
Aero-Med, Ltd.
CA28250
Not in Commercial Distribution

  • 50885380175914 ()
  • 10885380175916 ()
CA28250

  • Phlebotomy kit
hCG Combo Specialty Bar Code Label Collection Kit, IU Health Only
Aero-Med, Ltd.
CA25575
In Commercial Distribution

  • 50885380175846 ()
  • 20885380175845 ()
  • 10885380175848 ()
CA25575

  • Specimen mailer kit
Kit Viral Collection and Transport for Beth Israel Lahey Health Only
Aero-Med, Ltd.
CA34250A
In Commercial Distribution

  • 50885380199187 ()
  • 10885380199189 ()
CA34250A

  • General specimen collection kit
Viral Collection and Transport Kit, OP Swab, Bulk, Essentia Health Only
Aero-Med, Ltd.
CA34475A
Not in Commercial Distribution

  • 50885380183605 ()
  • 10885380183607 ()
CA34475A

  • General specimen collection kit IVD, clinical
Kit Adult Blood Culture Kurin 21G for Salina Regional Health Center
Aero-Med, Ltd.
CA56475
In Commercial Distribution

  • 50885380202825 ()
  • 10885380202827 ()
CA56475

  • Phlebotomy kit
Kit Drug Urine Screen for University of Virginia Health System Only
Aero-Med, Ltd.
CA53350
In Commercial Distribution

  • 50885380202719 ()
  • 10885380202711 ()
CA53350

  • Urine specimen collection kit IVD
#STETH SPRAGUE-RAP 22" TEAL
GF HEALTH PRODUCTS, INC.
602TL
In Commercial Distribution

  • M368602TL1 ()
602TL

  • Mechanical stethoscope
#STETH SPRAGUE-RAP 22" SEAFM
GF HEALTH PRODUCTS, INC.
602SF-GEL
In Commercial Distribution

  • M368602SFGEL1 ()
602SF-GEL

  • Mechanical stethoscope
STETH SPRAGUE-RAP 22" RED
GF HEALTH PRODUCTS, INC.
602R
In Commercial Distribution

  • M368602R1 ()
602R

  • Mechanical stethoscope
#STETH SPRAGUE-RAP 22" GEL
GF HEALTH PRODUCTS, INC.
602MV-GEL
In Commercial Distribution

  • M368602MVGEL1 ()
602MV-GEL

  • Mechanical stethoscope
STETH SPRAGUE-RAP 22" MAGENTA
GF HEALTH PRODUCTS, INC.
602MAG
In Commercial Distribution

  • M368602MAG1 ()
602MAG

  • Mechanical stethoscope
STETH SPRAGUE-RAP 22" LAV
GF HEALTH PRODUCTS, INC.
602L
In Commercial Distribution

  • M368602L1 ()
602L

  • Mechanical stethoscope
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