AccessGUDID - DEVICE: Enteral ENFit Transition Connector with cap for medication port (08056093720082)

GUDID

Device Identifier (DI) Information

Brand Name: Enteral ENFit Transition Connector with cap for medication port
Version or Model: H93842907EN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CEDIC SRL

Primary DI Number: 08056093720082
Issuing Agency: GS1
Commercial Distribution End Date:
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):	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?
61182	Enteral feeding/medication connector, non-sterile	A non-sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device.	Obsolete	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: cd391499-33f9-4194-8a1a-57c5be767ae7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 18, 2016