ThermaCare HeatWraps

Basic Information

• Brand Name: ThermaCare HeatWraps
• Primary DI: 00305733010396
• Version / Model: ThermaCare HeatWraps - Lower Back & Hip
• Company Name: PFIZER INC.
• Labeler DUNS: 079625650
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 2
• Public Version Date: 2020-12-17
• Public Version Status: Update
• Public Device Record Key: 6bbe7116-d772-45f1-9646-fd1cae49d188
• Distribution End Date: 2020-11-30

Device Description

THERMACARE LOWER BACK & HIP L/XL 8HR 10CT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMD	PACK, HOT OR COLD, DISPOSABLE	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00305733010396	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]