Convenience Bag - Convenience Bag, White Opaque, With Hand - TYPENEX MEDICAL LLC

Duns Number:600850213

Device Description: Convenience Bag, White Opaque, With Hand Protection

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More Product Details

Catalog Number

-

Brand Name

Convenience Bag

Version/Model Number

7000HP

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNY

Product Code Name

Basin, Emesis

Device Record Status

Public Device Record Key

6faf0d97-8808-4c06-8784-60c86029eb8d

Public Version Date

January 05, 2022

Public Version Number

1

DI Record Publish Date

December 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYPENEX MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 48