AccessGUDID - DEVICE: CARDINAL HEALTH (10885380153167)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 48-4100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 48-4100
Company Name: CARDINAL HEALTH 200, LLC

Primary DI Number: 10885380153167
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 300cc Canister w/o gel 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?
47404	Negative-pressure wound therapy system canister	A receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dee9e070-b713-4b21-bc3d-340006df6245
Public Version Date: March 17, 2025
Public Version Number: 3
DI Record Publish Date: May 24, 2023