AccessGUDID - DEVICE: Uni-Patch (10884521210738)

GUDID

Device Identifier (DI) Information

Brand Name: Uni-Patch
Version or Model: MS71000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MS71000
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521210738
Issuing Agency: GS1
Commercial Distribution End Date: February 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Pre-TENS Skin Prep Wipes

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):	No
Over the Counter (OTC):	Yes
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?
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOX	SOLVENT, ADHESIVE TAPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28d50192-61b1-42d0-8da6-94cb128591e1
Public Version Date: February 29, 2024
Public Version Number: 5
DI Record Publish Date: June 27, 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
20884527007544	50	10884521210738	2024-02-29	Not in Commercial Distribution	PACK_OR_INNER_PACK
90884527007543	100	10884521210738	2024-02-29	Not in Commercial Distribution	CASE