AccessGUDID - DEVICE: FifthPulse (00810084939406)

GUDID

Device Identifier (DI) Information

Brand Name: FifthPulse
Version or Model: 10 Pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FMN100535
Company Name: Jeg & Sons Inc.

Primary DI Number: 00810084939406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 789973646 *Terms of Use

Device Description: Color Changing Medical Cooling Gel Patch

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?
46556	Cold/cool therapy gel	A non-sterile, jelly-like substance in a container or in patch/strip form intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries or to reduce pain from tension headache/migraine (cold therapy), and/or for cooling at the skin surface to treat heat rash or sooth irritation (cool therapy). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMW	Adhesive Backed Thermal Skin Patches

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54b8910f-65f9-4e1f-b036-0b2b3368c6c3
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00810084939437 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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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