AccessGUDID - DEVICE: CARDINAL HEALTH (10885380097669)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 47-7000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 47-7000
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380097669
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: NPWT Polyurethane Drape

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?
47405	Negative-pressure wound therapy system drape	A sheet of plastic material designed to be placed over a wound dressing (e.g. open-cell foam or medicated gauze) to create a complete occlusion over and around a wound during negative pressure wound therapy (NPWT). This film dressing is typically vapour permeable, waterproof, and has an adhesive backing or edges applied against the wound dressing and surrounding healthy skin to create an airtight seal; it may be impregnated/coated with a gel (e.g., silicone) to minimize risk of trauma upon removal. It has a central opening, or an opening is made in or under it, to enable placement of the drain allowing negative pressure to reach the wound through the dressing. 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: Yes
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: 03555cb3-d756-40c7-9d2a-d50b023711a3
Public Version Date: August 03, 2021
Public Version Number: 7
DI Record Publish Date: July 12, 2016