AccessGUDID - DEVICE: ThermaCare HeatWraps (00305733010037)

GUDID

Device Identifier (DI) Information

Brand Name: ThermaCare HeatWraps
Version or Model: ThermaCare HeatWraps - Lower Back & Hip
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PFIZER INC.

Primary DI Number: 00305733010037
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 079625650 *Terms of Use

Device Description: THERMACARE LOWER BACK & HIP L/XL 8HR 2CT

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):	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?
37697	Exothermic heat therapy pack/patch	A device intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. It includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated; it may be available in a variety of forms (e.g., adhesive patch, belt containing packs). 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: d72bb2eb-a442-463c-b977-3ece6d64142f
Public Version Date: December 17, 2020
Public Version Number: 2
DI Record Publish Date: May 29, 2020