AccessGUDID - DEVICE: NeoMed Syringe-to-Syringe Coupler (10817584010557)

GUDID

Device Identifier (DI) Information

Brand Name: NeoMed Syringe-to-Syringe Coupler
Version or Model: CO-FEO-NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CO-FEO-NS
Company Name: NEOMED, INC.

Primary DI Number: 10817584010557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 480
Labeler D-U-N-S® Number*: 799772079 *Terms of Use

Device Description: NeoMed Oral Syringe Coupler, Female/Female, For Oral Use Only (12/Bag)

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):	No
Over the Counter (OTC):	Yes
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
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: 98978a0e-e85d-44c5-aa9f-7e05838b3188
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016