AccessGUDID - DEVICE: SNAP™ (00849554005464)

GUDID

Device Identifier (DI) Information

Brand Name: SNAP™
Version or Model: SKTF15X15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KCI USA, INC.

Primary DI Number: 00849554005464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102726734 *Terms of Use

Device Description: Snap Therapy System Snap Advanced Dressing Kit 15 cm X 15 cm Dressing Kit 13 cm X 13 cm Foam

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":	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?
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
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112341	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26c64ee5-227c-4ab3-8a75-e8b0b795d6d2
Public Version Date: September 09, 2020
Public Version Number: 7
DI Record Publish Date: September 24, 2016