Enteral - Enteral, ENFit® Accessories, Bottle Adaptor, - GBUK ENTERAL LIMITED

Duns Number:216643186

Device Description: Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 1 – 12-15mm

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More Product Details

Catalog Number

BAISO1-S

Brand Name

Enteral

Version/Model Number

BAISO1-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

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

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Device Record Status

Public Device Record Key

c2c3f49a-c206-4e8d-a0cb-818a4e362700

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

Additional Identifiers

Package DI Number

05060460848111

Quantity per Package

100

Contains DI Package

05060460848104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"GBUK ENTERAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 2