AccessGUDID - DEVICE: Enteral Funnel ENFit Transition Connector with cap (08056093720143)

GUDID

Device Identifier (DI) Information

Brand Name: Enteral Funnel ENFit Transition Connector with cap
Version or Model: F00074
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CEDIC SRL

Primary DI Number: 08056093720143
Issuing Agency: GS1
Commercial Distribution End Date: November 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 429471691 *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?
64469	ENFit/non-ISO80369-standardized linear connector	A small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIO	Enteral Specific Transition Connectors

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: 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: 2142677f-c356-4606-b5f9-e8377e6e36b9
Public Version Date: July 23, 2020
Public Version Number: 4
DI Record Publish Date: December 28, 2017