AccessGUDID - DEVICE: Gabriel 3-way EnFit Valve (00860000931366)

GUDID

Device Identifier (DI) Information

Brand Name: Gabriel 3-way EnFit Valve
Version or Model: GEV-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GEV-0001
Company Name: SYNCRO MEDICAL INNOVATIONS

Primary DI Number: 00860000931366
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001058887 *Terms of Use

Device Description: No description.

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":	Yes
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?
64700	ENFit/non-ISO80369-standardized small-bore multichannel connector	A small, non-powered, noninvasive, small-bore, tubular connector with three or more connections, which includes both an ENFit connection(s) [designed according to ISO 80369-3 for enteral applications] and a connection(s) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), designed to connect an enteral device(s) [e.g., enteral syringe, feeding tube, administration set] with an ENFit connection(s) typically to tubing or a syringe. It does not have a Luer or ENLock connection(s), and does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIF	Gastrointestinal Tubes With Enteral Specific Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201741	000

Device Exempt from Premarket Submission: No 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: 0a41ccf4-1fc5-4df0-89e8-740dd34f03df
Public Version Date: February 15, 2021
Public Version Number: 1
DI Record Publish Date: February 07, 2021