AccessGUDID - DEVICE: Enteral (10850002550037)

GUDID

Device Identifier (DI) Information

Brand Name: Enteral
Version or Model: VED-694
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VED-694
Company Name: GBUK ENTERAL LIMITED

Primary DI Number: 10850002550037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 216643186 *Terms of Use

Device Description: Enteral, ENFit® Accessories, Medicine Bottle Adapter, Single Use Size 5 – 24 – 26mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60539	Vial/bottle adaptor, non-hermetic	A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYX	DISPENSER, LIQUID MEDICATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0649c351-e2be-44f3-8a06-7799b1192f75
Public Version Date: November 09, 2022
Public Version Number: 1
DI Record Publish Date: November 01, 2022