AccessGUDID - DEVICE: CARDINAL HEALTH (10885380153143)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 48-2500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 48-2500
Company Name: CARDINAL HEALTH 200, LLC

Primary DI Number: 10885380153143
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 112164780 *Terms of Use

Device Description: NPWT Y Connector Occlusion Detection

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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?
64696	Non-ISO80369-standardized small-bore multichannel connector, single-use	A small, non-powered, noninvasive, small-bore tubular connector with three or more connections (typically barbed, bayonet, conical, threaded and/or non-Luer-slip), none of which are designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), intended to connect three or more luminal devices (e.g., tubing, container) with each other during a medical procedure. It is typically T-, Y- or cross-shaped; it does not incorporate a filter, valve, clamp, tubing or puncturing component, and is not a dedicated gas-line connector. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMP	negative pressure wound therapy Powered suction pump

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: 20f4aba9-f2d9-47c6-8cf9-2071e60377b5
Public Version Date: March 17, 2025
Public Version Number: 5
DI Record Publish Date: November 12, 2019