AccessGUDID - DEVICE: Kendall (10885380165177)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 49-6800
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 49-6800
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380165177
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: NPWT IM Dressing Kit OD, 15x20cm

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:	Yes
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?
47956	Negative-pressure wound therapy system dressing set	A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. 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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 13329069-bfa7-4806-87fa-1ee9e8d37cc9
Public Version Date: June 30, 2022
Public Version Number: 4
DI Record Publish Date: August 18, 2020