AccessGUDID - DEVICE: V.A.C. VERAFLO Cleanse Choice™ (00849554006256)

GUDID

Device Identifier (DI) Information

Brand Name: V.A.C. VERAFLO Cleanse Choice™
Version or Model: ULTVCC05LG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KCI USA, INC.

Primary DI Number: 00849554006256
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102726734 *Terms of Use

Device Description: V.A.C. VERAFLO Cleanse Choice™ DRESSING LARGE

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
61145	Irrigation negative-pressure wound therapy dressing	A sterile dressing intended to treat open wounds (e.g., acute, traumatic, and chronic) that can only heal by secondary intention, through use of suction combined with instillation/aspiration of wound treatment solutions (e.g., saline) over the wound bed provided by an irrigation negative-pressure wound therapy unit. It typically consists of a foam dressing, polymer drape and attached tubing. It is intended to help reduce oedema, promote granulation tissue formation, and remove exudates and infectious material. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41d0ae76-82a4-4221-bf15-e63ee255bf26
Public Version Date: September 09, 2020
Public Version Number: 2
DI Record Publish Date: June 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00849554006263	5	00849554006256		In Commercial Distribution	5 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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