AccessGUDID - DEVICE: CARDINAL HEALTH (10885380103513)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 6702232
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6702232
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380103513
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Cardinal Health NPWT PRO at Home NPWT Therapy Device

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:	No
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?
47408	Negative-pressure wound therapy system pump, electric	A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).	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 -12 and 43 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a07f34e-3f3c-4298-b90c-3f7ac112696f
Public Version Date: April 30, 2020
Public Version Number: 5
DI Record Publish Date: July 12, 2016