AccessGUDID - DEVICE: WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH (00310742098426)

GUDID

Device Identifier (DI) Information

Brand Name: WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH
Version or Model: 9842
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MENTHOLATUM COMPANY, THE

Primary DI Number: 00310742098426
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002105757 *Terms of Use

Device Description: WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH. Drug Free. 1 Large Patch. 5" x 4" (13 x 10 cm) EACH.

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?
40555	Hot/cold therapy pack, single-use	A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMD	Pack, Hot Or Cold, Disposable

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: 457a883b-bce5-4f4e-a91b-c94d9ab45189
Public Version Date: February 17, 2020
Public Version Number: 1
DI Record Publish Date: February 07, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00310742998429	120	00310742098426	In Commercial Distribution	Case
00310742998436	24	00310742098433	In Commercial Distribution	Case
00310742098433	4	00310742098426	In Commercial Distribution	Carton