AccessGUDID - DEVICE: SNAP™ (00849554006058)

GUDID

Device Identifier (DI) Information

Brand Name: SNAP™
Version or Model: SNPA125US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KCI USA, INC.

Primary DI Number: 00849554006058
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 125mmHg Therapy Cartridge 60ml

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60884	Negative-pressure wound therapy system pump, mechanical	A portable 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, venous/diabetic/pressure ulcers, surgical wounds, flaps and grafts. It creates a vacuum by non-electric mechanical means (e.g., spring) and is connected to a NPWT system dressing set. 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: No
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: 218de46d-0392-4869-a339-ffa2c481a27e
Public Version Date: September 09, 2020
Public Version Number: 8
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20849554006052	10	00849554006058		In Commercial Distribution	10 PACK
00849554007086	10	00849554006058		In Commercial Distribution	10 Pack

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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