Bioseal - Enternal Feeding Tube 12 Fr - BIOSEAL

Duns Number:186968939

Device Description: Enternal Feeding Tube 12 Fr

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More Product Details

Catalog Number

-

Brand Name

Bioseal

Version/Model Number

17326/20

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Device Record Status

Public Device Record Key

329f2964-5d25-4b4c-863f-e0fdff9fb42f

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Additional Identifiers

Package DI Number

10630094173266

Quantity per Package

20

Contains DI Package

00630094173269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BIOSEAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 86