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

Duns Number:216643186

Device Description: Enteral, ENFit® Accessories, Bottle Adaptor, Single Use Size 3 – 17 – 20.5mm

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More Product Details

Catalog Number

BAISO3-S

Brand Name

Enteral

Version/Model Number

BAISO3-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

5a177109-7894-457b-b5cd-bb45940e023b

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

Additional Identifiers

Package DI Number

05060460848180

Quantity per Package

12

Contains DI Package

05060460848173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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