MedSource Emesis Bag - Zip Bag - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Zip Bag

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More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Emesis Bag

Version/Model Number

MS-17365

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

FNY

Product Code Name

Basin, Emesis

Device Record Status

Public Device Record Key

8ac51f46-30b3-421d-903f-798f25cb2f04

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Additional Identifiers

Package DI Number

00840155408036

Quantity per Package

40

Contains DI Package

00816703025499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90