AccessGUDID - DEVICE: ENFit Large Bore Straw (00350770000367)

GUDID

Device Identifier (DI) Information

Brand Name: ENFit Large Bore Straw
Version or Model: PEXT-6STBNC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PEXT-6STBNC
Company Name: Avanos Medical, Inc.

Primary DI Number: 00350770000367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: 6" ENFit Straw Large Bore Sterile Purp

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
62258	Oral/enteral syringe drawing-up straw	A flexible, blunt, tubular device intended to be connected to an oral/enteral syringe for the convenient transfer of fluids (e.g., dissolved medication, liquid nutrition) from an open container into the syringe prior to oral/enteral administration; it is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILC	UTENSIL, EATING

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 5c038224-1d3c-48d5-917c-30d9419b9ff0
Public Version Date: June 22, 2023
Public Version Number: 3
DI Record Publish Date: April 23, 2021