VYGON - BIOPATCH PEDIATRIC DRESSING KIT - Vygon Corporation

Duns Number:120818216

Device Description: BIOPATCH PEDIATRIC DRESSING KIT

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More Product Details

Catalog Number

AMS-8952CP-3

Brand Name

VYGON

Version/Model Number

AMS-8952CP-3

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

OXQ

Product Code Name

Dressing change tray

Device Record Status

Public Device Record Key

93bfcdfc-27c9-4ec5-a8fd-d7a02d15b111

Public Version Date

October 06, 2020

Public Version Number

4

DI Record Publish Date

October 10, 2017

Additional Identifiers

Package DI Number

38498840010991

Quantity per Package

20

Contains DI Package

08498840010990

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