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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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Transystem™ - 28053326001219

TRANSYSTEM AMIES W/O CH. TWISTED APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
190C.USE
In Commercial Distribution

  • 38053326001216 ()
  • 28053326001219 ()
  • 18053326001212 ()
190C.USE

  • General specimen collection kit

Transystem™ - 28053326000908

TRANSYSTEM LQ STUART PLASTIC APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
141C.USE
In Commercial Distribution

  • 38053326000905 ()
  • 28053326000908 ()
  • 18053326000901 ()
  • 68053326000906 ()
141C.USE

  • General specimen collection kit

Transystem™ - 28053326000892

TRANSYSTEM LQ AMIES PLASTIC APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
140C.USE
In Commercial Distribution

  • 38053326000899 ()
  • 28053326000892 ()
  • 18053326000895 ()
  • 68053326000890 ()
140C.USE

  • General specimen collection kit

Transystem™ - 28053326000885

TRANSYSTEM LQ STUART DUAL PLASTIC APPLICATORS RAYON TIPPED
COPAN ITALIA SPA
139C.USE
In Commercial Distribution

  • 38053326000882 ()
  • 28053326000885 ()
  • 18053326000888 ()
139C.USE

  • General specimen collection kit

Transystem™ - 28053326000878

TRANSYSTEM CARY BLAIR MEDIUM PLASTIC APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
132C.USE
In Commercial Distribution

  • 38053326000875 ()
  • 28053326000878 ()
  • 18053326000871 ()
  • 68053326000876 ()
132C.USE

  • General specimen collection kit

Transystem™ - 28053326000861

TRANSYSTEM AMIES WITH CH ALUMINIUM APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
116C.USE
In Commercial Distribution

  • 38053326000868 ()
  • 28053326000861 ()
  • 18053326000864 ()
  • 68053326000869 ()
116C.USE

  • General specimen collection kit

Transystem™ - 28053326000847

TRANSYSTEM AMIES W/O CH ALUMINIUM APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
111C.USE
In Commercial Distribution

  • 38053326000844 ()
  • 28053326000847 ()
  • 18053326000840 ()
  • 68053326000845 ()
111C.USE

  • General specimen collection kit

UTM® - 28053326000700

Medium + Pernasal sterile Flocked Swab
COPAN ITALIA SPA
305C
In Commercial Distribution

  • 38053326000707 ()
  • 28053326000700 ()
  • 18053326000703 ()
305C

  • General specimen collection kit

Transystem™ - 28053326000601

TRANSYSTEM AMIES WITH CH PLASTIC APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
114C.USE
In Commercial Distribution

  • 38053326000608 ()
  • 28053326000601 ()
  • 18053326000604 ()
  • 68053326000609 ()
114C.USE

  • General specimen collection kit

Transystem™ - 28053326000595

TRANSYSTEM AMIES W/O CH ALUMINIUM APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
110C.USE
In Commercial Distribution

  • 38053326000592 ()
  • 28053326000595 ()
  • 18053326000598 ()
  • 68053326000593 ()
110C.USE

  • General specimen collection kit

Transystem™ - 28053326000588

TRANSYSTEM AMIES W/O CH PLASTIC APPLICATOR RAYON TIPPED
COPAN ITALIA SPA
108C.USE
In Commercial Distribution

  • 38053326000585 ()
  • 28053326000588 ()
  • 18053326000581 ()
  • 68053326000586 ()
108C.USE

  • General specimen collection kit

UTM® - 28053326000502

MINI UTM KIT 1 mL Medium + Pernasal sterile Flocked Swab
COPAN ITALIA SPA
360C
In Commercial Distribution

  • 38053326000509 ()
  • 28053326000502 ()
  • 18053326000505 ()
360C

  • General specimen collection kit

Puritan - 30609576900786

Puritan Cary-Blair Medium, 5 ml
Puritan Medical Products
CB-500
In Commercial Distribution

  • 00609576900785 ()
  • 30609576900786 ()
CB-500

  • General-purpose absorbent tip applicator/swab, single-use

Puritan - 30609576900779

Puritan Cary-Blair Medium, 2 ml
Puritan Medical Products
CB-200
In Commercial Distribution

  • 00609576900778 ()
  • 30609576900779 ()
CB-200

  • General-purpose absorbent tip applicator/swab, single-use

PRAS Liquid Dental Transport Medium (LDT) - 00810048901289

AS-916 Liquid Dental Transport Medium (LDT) is a buffered mineral salt based liquid medium with reducing agents designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 1 mL fill volume. 19 x 40 mm hungate-capped tube. Transparent colorless liquid. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-916
In Commercial Distribution

  • 00810048902415 ()
  • 00810048901289 ()
AS-916

  • Anaerobic transport medium IVD

PRAS Anaerobic Tissue Transport Medium (ATTM) - 00810048901272

AS-919 Anaerobic Tissue Transport Medium (ATTM) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 8 mL fill volume. 28 x 57 screw top vial. Transparent colorless semi-solid. 5 tubes per pack.
ANAEROBE SYSTEMS
AS-919
In Commercial Distribution

  • 00810048902446 ()
  • 00810048901272 ()
AS-919

  • Anaerobic transport medium IVD

PRAS Anaerobic Dental Transport Medium (DTM) - 00810048901265

AS-920 Anaerobic Dental Transport Medium (DTM) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 5 mL fill volume. 19 x 40 mm hungate-capped tube. Transparent colorless semi-solid medium. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-920
In Commercial Distribution

  • 00810048902453 ()
  • 00810048901265 ()
AS-920

  • Anaerobic transport medium IVD

PRAS Anaerobic Transport Medium - Surgery Pack (ATM-SP) - 00810048901258

AS-914 Anaerobic Transport Medium - Surgery Pack (ATM-SP) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Individually packaged and sterilized for use in surgical setting. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless semi-solid medium. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-914
In Commercial Distribution

  • 00810048902408 ()
  • 00810048901258 ()
AS-914

  • Anaerobic transport medium IVD

PRAS Anaerobic Transport Medium (ATM) - 00810048901241

AS-911 Anaerobic Transport Medium (ATM) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 6 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent colorless semi-solid medium. 10 tubes per pack.
ANAEROBE SYSTEMS
AS-911
In Commercial Distribution

  • 00810048902392 ()
  • 00810048901241 ()
AS-911

  • Anaerobic transport medium IVD

PRAS Anaerobic Tissue Transport Medium - Surgery Pack (ATTM-SP) - 00810048901425

AS-915 Anaerobic Tissue Transport Medium - Surgery Pack (ATTM-SP) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Individually packaged and sterilized for use in a surgical setting. Pre-reduced anaerobically sterilized (PRAS). 8 mL fill volume. 28 x 57 mm screw top vial. Transparent colorless semi-solid medium. 5 tubes per pack.
ANAEROBE SYSTEMS
AS-915
In Commercial Distribution

  • 00810048901432 ()
  • 00810048901425 ()
AS-915

  • Anaerobic transport medium IVD

Gongdong - 06947462492476

INDIVIDUALLY PACKAGED,10mL Virus Collection and Preservation System(VTM),G1029FN80 Swab,3mL VTM medium
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
G1026V3
In Commercial Distribution

  • 86947462492472 ()
  • 06947462492476 ()
  • 16947462492473 ()


  • Inoculating tool IVD, manual

Gongdong - 16947462494293

Disposable urine collection tube, Additive is boric acid, specification 13×100 PET 7ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD070UBW
In Commercial Distribution

  • 06947462494296 ()
  • 16947462494293 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494279

Disposable urine collection tube, Additive is boric acid, specification 13×75 PET 4ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD040UBW
In Commercial Distribution

  • 06947462494272 ()
  • 16947462494279 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462492817

Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 10ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD100UB
In Commercial Distribution

  • 06947462492810 ()
  • 16947462492817 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494347

Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 8ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD080UACW
In Commercial Distribution

  • 06947462494340 ()
  • 16947462494347 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494330

Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 8ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD080UAC
In Commercial Distribution

  • 06947462494333 ()
  • 16947462494330 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494323

Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 10ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD100UBW
In Commercial Distribution

  • 06947462494326 ()
  • 16947462494323 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494316

Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 8ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD080UBW
In Commercial Distribution

  • 06947462494319 ()
  • 16947462494316 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494309

Disposable urine collection tube, Additive is boric acid, specification 16×100 PET 8ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD080UB
In Commercial Distribution

  • 06947462494302 ()
  • 16947462494309 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494286

Disposable urine collection tube, Additive is boric acid, specification 13×100 PET 7ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD070UB
In Commercial Distribution

  • 06947462494289 ()
  • 16947462494286 ()


  • Evacuated urine specimen container IVD, preservative

Gongdong - 16947462494262

Disposable urine collection tube, Additive is boric acid, specification 13×75 PET 4ml
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
GD040UB
In Commercial Distribution

  • 06947462494265 ()
  • 16947462494262 ()


  • Evacuated urine specimen container IVD, preservative

iClean - 16974488990942

No Description
Huachenyang (Shenzhen) Technology Co., Ltd
CY-F003-40 (NGS)
In Commercial Distribution

  • 26974488990949 ()
  • 16974488990942 ()
  • 06974488990945 ()


  • General specimen container IVD, additive/medium

iClean - 16974488990447

Inactivated transport medium
Huachenyang (Shenzhen) Technology Co., Ltd
CY-F003-40
In Commercial Distribution

  • 26974488990444 ()
  • 16974488990447 ()
  • 06974488990440 ()


  • General specimen container IVD, additive/medium

iClean - 16974488990218

No Description
Huachenyang (Shenzhen) Technology Co., Ltd
CY-93050R-TS
In Commercial Distribution

  • 26974488990215 ()
  • 16974488990218 ()
  • 06974488990211 ()


  • General specimen collection kit IVD, clinical

iClean - 16974488990201

The product consists of a tube with viral transport medium and two model sampling swab (CY-93050&CY-96000).
Huachenyang (Shenzhen) Technology Co., Ltd
CY-F005-20
In Commercial Distribution

  • 26974488990208 ()
  • 16974488990201 ()
  • 06974488990204 ()


  • General specimen collection kit IVD, clinical

iClean - 16974488990195

The product consists of a tube with viral transport medium and one piece of sterile sampling swab(CY-93050).
Huachenyang (Shenzhen) Technology Co., Ltd
CY-F005-20
In Commercial Distribution

  • 26974488990192 ()
  • 16974488990195 ()
  • 06974488990198 ()


  • General specimen collection kit IVD, clinical

iClean - 16974488990188

Non-inactivated transport medium
Huachenyang (Shenzhen) Technology Co., Ltd
CY-F003-40
In Commercial Distribution

  • 26974488990185 ()
  • 16974488990188 ()
  • 06974488990181 ()


  • General specimen container IVD, additive/medium

iClean - 16974488990171

No Description
Huachenyang (Shenzhen) Technology Co., Ltd
CY-93050R-TS
In Commercial Distribution

  • 26974488990178 ()
  • 16974488990171 ()
  • 06974488990174 ()


  • General specimen collection kit IVD, clinical

iClean - 16974488990164

No Description
Huachenyang (Shenzhen) Technology Co., Ltd
CY-93050R-TS
In Commercial Distribution

  • 26974488990161 ()
  • 16974488990164 ()
  • 06974488990167 ()


  • General specimen collection kit IVD, clinical

BioSci™ - 16973471969996

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

  • 06973471969999 ()
  • 16973471969996 ()
  • 26973471969993 ()
  • 06973471960927 ()
6991111

  • General specimen collection kit IVD, clinical

BioSci™ - 16973471969941

3 mL of Transport Medium in screw-cap tube
Shenzhen Dakewe Bio-engineering Co., Ltd
VM
In Commercial Distribution

  • 26973471969948 ()
  • 16973471969941 ()
  • 06973471969944 ()
  • 06973471961092 ()
6991014

  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600361

1 mL viral transport medium/vial, with a regular swab and a minitip swab
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221012
In Commercial Distribution

  • 26972698600368 ()
  • 16972698600361 ()
  • 06972698600364 ()


  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600354

1 mL viral transport medium/vial, with a regular swab
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221011
In Commercial Distribution

  • 26972698600351 ()
  • 16972698600354 ()
  • 06972698600357 ()


  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600347

1 mL viral transport medium/vial, with a minitip swab.
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221010
In Commercial Distribution

  • 26972698600344 ()
  • 16972698600347 ()
  • 06972698600340 ()


  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600323

3 mL viral transport medium/vial, with a regular swab and a minitip swab.
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221008
In Commercial Distribution

  • 06972698600326 ()
  • 16972698600323 ()
  • 26972698600320 ()


  • General specimen container IVD, additive/medium

SNT Biotech - 16973471969859

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

  • 06973471969852 ()
  • 16973471969859 ()
  • 26973471969856 ()
  • 06973471967629 ()
6991311

  • General specimen collection kit IVD, clinical

KaiBiLi Extended ViralTrans - 16972698600330

1 mL viral transport medium/vial
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221009
In Commercial Distribution

  • 26972698600337 ()
  • 16972698600330 ()
  • 06972698600333 ()


  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600316

3 mL viral transport medium/vial, with a regular swab
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221007
In Commercial Distribution

  • 06972698600319 ()
  • 16972698600316 ()
  • 26972698600313 ()


  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600309

3 mL viral transport medium/vial,with a minitip swab
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221006
In Commercial Distribution

  • 16972698600309 ()
  • 06972698600302 ()
  • 26972698600306 ()


  • General specimen container IVD, additive/medium

KaiBiLi Extended ViralTrans - 16972698600293

3 mL viral transport medium/vial
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
M221001
In Commercial Distribution

  • 06972698600296 ()
  • 16972698600293 ()
  • 26972698600290 ()


  • General specimen container IVD, additive/medium
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