AccessGUDID - DEVICE: Y-Port Feeding Adapter (00842071131661)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Port Feeding Adapter
Version or Model: E4-2012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E4-2012, 4-2012
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071131661
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: 12FR Y-Port Replacement (Pouched)

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?
64467	Luer/non-ISO80369-standardized linear connector, single-use	A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other end (typically barbed, bayonet, collet, conical, threaded or non-Luer-slip) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing or an external puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043027	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
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: 193f7e09-6c1c-410c-8e87-aeda2b609cf2
Public Version Date: August 07, 2023
Public Version Number: 2
DI Record Publish Date: July 05, 2023