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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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BioSci™ - 16977644780029

3 mL of Transport Medium in screw-cap tube,One regular flocking swab with 3cm breaking point
Shenzhen Dakewe Bio-engineering Co., Ltd
VO
In Commercial Distribution

  • 26977644780026 ()
  • 16977644780029 ()
  • 06977644780022 ()
  • 06973471960958 ()
6991321

  • General specimen collection kit IVD, clinical

BioSci™ - 16977644780012

1 mL of Transport Medium in screw-cap tube, with regular flocking swab.
Shenzhen Dakewe Bio-engineering Co., Ltd
VO
In Commercial Distribution

  • 26977644780019 ()
  • 16977644780012 ()
  • 06977644780015 ()
  • 06973471960941 ()
6991121

  • General specimen collection kit IVD, clinical

BioSci™ - 16977644780005

3 mL of Transport Medium in screw-cap tube, with minitip flocking swab.
Shenzhen Dakewe Bio-engineering Co., Ltd
VN
In Commercial Distribution

  • 26977644780002 ()
  • 16977644780005 ()
  • 06977644780008 ()
  • 06973471960934 ()
6991311

  • General specimen collection kit IVD, clinical

Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500 B/V Filter, CO2 Port and Flex - 00840117305359

Adult, Tidal Volume Range(250-1500mL), Media(Foam + Flat Media), Dead Space(89 (60)mL, Breathing Resistance(2.0cm H2O at 60L /min), Weight (45g)
Dynarex Corporation
30106
In Commercial Distribution

  • 00840117305366 ()
  • 00840117305359 ()


  • Heat/moisture exchanger/microbial medical gas filter

N/A - 00816576028122

Columbia CNA Agar with Esculin / Hektoen Enteric (HE) Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective and differential medium used for the isolation and differentiation of gram-negative enteric pathogens.
HARDY DIAGNOSTICS
J67
In Commercial Distribution

  • 00816576028115 ()
  • 00816576028122 ()
J67

  • Multiple formulation agar culture medium IVD

N/A - 00816576027149

Rose / MacConkey Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics MacConkey Agar is recommended for use as a selective and differential medium for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens), on the basis of lactose fermentation. Hardy Diagnostics Rose Agar is recommended for use as a selective growth medium for the cultivation and isolation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
J85
In Commercial Distribution

  • 00816576027132 ()
  • 00816576027149 ()
J85

  • Multiple formulation agar culture medium IVD

N/A - 00816576027040

Bile Esculin Agar (BEA) with Azide / Columbia CNA Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Bile Esculin with Azide Media are recommended for the isolation and differentiation of group D streptococci from non-group D streptococci. Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
J66
In Commercial Distribution

  • 00816576027033 ()
  • 00816576027040 ()
J66

  • Multiple formulation agar culture medium IVD

N/A - 00816576026944

Columbia CNA / EMB Agar, Levine, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens.
HARDY DIAGNOSTICS
J52
In Commercial Distribution

  • 00816576026937 ()
  • 00816576026944 ()
J52

  • Multiple formulation agar culture medium IVD

N/A - 00816576026531

BBE/PEA Biplate, 15x100 biplate, 10/pk (Section i: Bacteroides Bile Esculin Agar; Section II: Anerobic Phenylethyl Alcohol Agar) For the selective isolation and detection of anaerobic bacteria
HARDY DIAGNOSTICS
J122
Not in Commercial Distribution

  • 00816576024483 ()
  • 00816576026531 ()
J122

  • Multiple formulation agar culture medium IVD

N/A - 00816576026487

Columbia CNA / BluEcoli™, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora.
HARDY DIAGNOSTICS
J116
Not in Commercial Distribution

  • 00816576026470 ()
  • 00816576026487 ()
J116

  • Multiple formulation agar culture medium IVD

N/A - 00816576026401

Sabouraud Dextrose (SabDex) Agar with Chloramphenicol and Gentamicin / DTM, 15x100mm Biplate, 15ml/15ml. Hardy Diagnostics Dermatophyte Test Medium (DTM) is a selective and differential medium recommended for the cultivation and isolation of pathogenic dermatophytic fungi.
HARDY DIAGNOSTICS
J107
In Commercial Distribution

  • 00816576026395 ()
  • 00816576026401 ()
J107

  • Multiple formulation agar culture medium IVD

N/A - 00816576026388

BBE / LKV, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Bacteroides Bile Esculin Agar (BBE) is recommended for use in the rapid isolation and presumptive identification of Bacteroides fragilis group. Hardy Diagnostics Laked Blood with Kanamycin and Vancomycin Agar is recommended for use in the isolation and partial identification of anaerobic microorganisms.
HARDY DIAGNOSTICS
J102
In Commercial Distribution

  • 00816576024407 ()
  • 00816576026388 ()
J102

  • Multiple formulation agar culture medium IVD

N/A - 00816576025817

TSA / CET (Cetrimide Selective Agar) / MSA (Mannitol Salt Agar), USP, 15x100mm Triplate, 7ml/section. Hardy Diagnostics Cetrimide Selective Agar is recommended for the selective isolation and identification of Pseudomonas aeruginosa. Hardy Diagnostics Mannitol Salt Agar (MSA) is recommended for use as a selective and differential medium for the isolation of pathogenic staphylococci. Hardy Diagnostics Tryptic Soy Agar (TSA), USP is recommended for use as a general growth medium for the detection and enumeration of microorganisms from non-clinical samples.
HARDY DIAGNOSTICS
J330
In Commercial Distribution

  • 00816576024667 ()
  • 00816576025817 ()
J330

  • Multiple formulation agar culture medium IVD

AnaeroGRO - 00816576024414

BBE/LKV Biplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selective, and differential medium recommended for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila spp.
HARDY DIAGNOSTICS
AG061
In Commercial Distribution

  • 00816576024414 ()
AG061

  • Multiple formulation agar culture medium IVD

N/A - 00816576023622

CLED/;EMB, 15x100, Biplate, 10/pk For the isolation and differentiation of microorganisms from clinical specimens, especially for the detection of urinary tract infections. Section I: CLED Agar Section II: EMB Agar
HARDY DIAGNOSTICS
2110
Not in Commercial Distribution

  • 00816576023615 ()
  • 00816576023622 ()
2110

  • Multiple formulation agar culture medium IVD

N/A - 00816576023561

MacConkey/Columbia CNA, 15x100, Biplate, 10/pk For the isolation and differentiation of microorganisms. Section I: MacConkey Agar Section II: Columbia CNA
HARDY DIAGNOSTICS
2004
Not in Commercial Distribution

  • 00816576023554 ()
  • 00816576023561 ()
2004

  • Multiple formulation agar culture medium IVD

Resp-O2 Heat Moisture Exchanger (HMEF) 1000 B/V CO2 Flex Tube - 00840117305274

Adult, Tidal Volume Range (150-1000 mL) Media (Foam + Flat Media), Dead Space (105 (70) mL), Breathing Resistance (1.9cm H2O at 60L / min), Weight (33g)
Dynarex Corporation
30101
In Commercial Distribution

  • 00840117305281 ()
  • 00840117305274 ()


  • Heat/moisture exchanger/microbial medical gas filter

Floor Stand - 37630039301997

No Description
Bracco Injeneering SA
017410
In Commercial Distribution

  • 37630039301997 ()
017410

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

IV Pole - 37630039301980

No Description
Bracco Injeneering SA
017528
In Commercial Distribution

  • 37630039301980 ()
017528

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector Mounting Arm, Right - 37630039300631

No Description
Bracco Injeneering SA
017418
In Commercial Distribution

  • 37630039300631 ()
017418

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Articulating arm - 37630039300617

No Description
Bracco Injeneering SA
017416
In Commercial Distribution

  • 37630039300617 ()
017416

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

EDA Clip - 37630039300686

No Description
Bracco Injeneering SA
015781
In Commercial Distribution

  • 37630039300686 ()
015781

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector Mounting Arm, Left - 37630039300624

No Description
Bracco Injeneering SA
017417
In Commercial Distribution

  • 37630039300624 ()
017417

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

EmpowerCTA®+ Injector System with EDA - 47630039300812

Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300822
Bracco Injeneering SA
017383
Not in Commercial Distribution

017383

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

EmpowerCTA®+ Injector System - 47630039300430

Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN : 37630039300747
Bracco Injeneering SA
017285
In Commercial Distribution

  • 47630039300430 ()
017285

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

CT Expres™ 3D - 47630039300096

Composed of : 1 x CT Exprès™ - Injector Unit GTIN : 37630039300105 2 x CT Exprès™ - Control Panel GTIN : 37630039300112
Bracco Injeneering SA
651207
In Commercial Distribution

  • 47630039300096 ()
651207

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector - 17630039301450

No Description
Bracco Injeneering SA
102410
In Commercial Distribution

  • 37630039301454 ()
  • 17630039301450 ()
  • 17630039300798 ()
102410

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector head - 17630039301047

No Description
Bracco Injeneering SA
102410
Not in Commercial Distribution

  • 37630039301041 ()
  • 17630039301047 ()
  • 17630039301450 ()


  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector Head - 17630039300910

No Description
Bracco Injeneering SA
102410
Not in Commercial Distribution

  • 37630039300891 ()
  • 17630039300910 ()


  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector - 17630039300798

No Description
Bracco Injeneering SA
102410
Not in Commercial Distribution

  • 37630039300822 ()
  • 17630039300798 ()
  • 17630039300743 ()
102410

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

Injector - 17630039300743

No Description
Bracco Injeneering SA
102410
Not in Commercial Distribution

  • 37630039300747 ()
  • 17630039300743 ()
102410

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

EDA Module Kit - 17630039300422

No Description
Bracco Injeneering SA
017354
In Commercial Distribution

  • 37630039300426 ()
  • 17630039300422 ()
017354

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

CT Exprès™ - Bottle Insulator - 17630039300156

2 x CT Exprès™ - Bottle Insulator contained in packaging GTIN : 37630039300105
Bracco Injeneering SA
640131
In Commercial Distribution

  • 17630039300156 ()
640131

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

CT Exprès™ - Injector Unit - 17630039300101

No Description
Bracco Injeneering SA
651195
In Commercial Distribution

  • 37630039300105 ()
  • 17630039300101 ()
651195

  • CT contrast medium injection system, line-powered, stationary
  • CT contrast medium injection system, line-powered, mobile

NORDENT MANUFACTURING INC - 00840018623118

CURETTE, DOUBLE END, TRADE IN, UNIVERSITY OF CALIFORNIA RULE #3-4, #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCUC3-4
In Commercial Distribution

  • 00840018623118 ()


  • Manual dental scaler, reusable

Integra® Miltex® - 10381780258025

Integra® Miltex® Integra® Miltex® University Of Oklahoma Cassette, Endodontic
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-139000UOK
In Commercial Distribution

  • H8343139000UOK1 ()
  • 10381780258025 ()
3-139000UOK

  • Device sterilization/disinfection container, reusable

devemed - 04061644030934

Cheek retractor | 135 mm "University of Cawood-Minnesota" modified acc. to Dr. Ziv Mazor
devemed GmbH
998-21
In Commercial Distribution

  • 04061644030934 ()


  • Hand-held dental retractor

V. Mueller - 10885403108945

UNIVERSITY OF IOWA COTTON APPLICATOR FLAT, PARTIALLY SERRATED TIP OVERALL LENGTH 6" (15.2CM)
CAREFUSION 2200, INC
RH240
Not in Commercial Distribution

  • 10885403108945 ()
RH240

  • General-purpose absorbent tip applicator/swab, reusable

Ambler Surgical - 00190660143312

University of Chicago rake retractor, 9 3/4'', 4 blunt prongs, square handle
AMBLER SURGICAL CORP.
University of Chicago rake retractor
In Commercial Distribution

  • 00190660143312 ()
73-420

  • Hand-held surgical retractor, reusable

HELMUT ZEPF - EZPF2420704C0

UNIV. CURETTE PERIODONT., ZEPF-BIONIK COLUMBIA UNIVERSITY FIG.4R/4L COBALT BLUE, INSERTS INTERCHANGEABLE
Helmut Zepf Medizintechnik GmbH
24.207.04C
In Commercial Distribution

  • EZPF2420704C0 ()
24.207.04C

  • Periodontal curette

HELMUT ZEPF - EZPF2420702C0

UNIV. CURETTE PERIODONT., ZEPF-BIONIK COLUMBIA UNIVERSITY FIG.2R/2L COBALT BLUE, INSERTS INTERCHANGEABLE
Helmut Zepf Medizintechnik GmbH
24.207.02C
In Commercial Distribution

  • EZPF2420702C0 ()
24.207.02C

  • Periodontal curette

Molecular Transport Media (MTM) 3ml - 07898996204655

The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.
A. L. B. LUZ
MEI00211
In Commercial Distribution

  • 07898996204655 ()
  • 17898996204652 ()
MEI00211

  • Oral/upper respiratory tract specimen collection kit

Molecular Transport Media (MTM) 2ml - 07898996204648

The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.
A. L. B. LUZ
MEI00218
In Commercial Distribution

  • 07898996204648 ()
  • 17898996204645 ()
MEI00218

  • Oral/upper respiratory tract specimen collection kit

Viral Transport Media (VTM) 3ml - 07898996204631

The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.
A. L. B. LUZ
MEI00175
In Commercial Distribution

  • 07898996204631 ()
  • 17898996204638 ()
MEI00175

  • General specimen collection kit IVD, clinical

SpO2.COM® pediatric SpO2 disposable sensor - 10843997000489

No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use

SpO2.COM® Infant SpO2 disposable sensor - 10843997000472

No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

SpO2.COM® NRC-SL2 Spacelabs Replacement Cable - 00843997001434

No Description
MASIMO CORPORATION
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-P8 Patient Cable, 3M - 00843997001427

No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-SL Spacelabs Replacement Cable - 00843997001410

No Description
MASIMO CORPORATION
1900
In Commercial Distribution

  • 00843997001410 ()


  • Electrical-only medical device connection cable, reusable
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