HEALTH CARE TECHNOLOGY - VAD ACCESS KIT - Vygon Corporation

Duns Number:120818216

Device Description: VAD ACCESS KIT

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More Product Details

Catalog Number

HCT8874VA-VA

Brand Name

HEALTH CARE TECHNOLOGY

Version/Model Number

HCT8874VA-VA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OWL

Product Code Name

Peripheral catheter insertion kit

Device Record Status

Public Device Record Key

b5a42c4d-7db5-416c-924a-ac228a2fba03

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

April 17, 2019

Additional Identifiers

Package DI Number

38498840012438

Quantity per Package

20

Contains DI Package

08498840012437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYGON CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 833