BodyMed

Basic Information

• Brand Name: BodyMed
• Primary DI: 00815802018715
• Version / Model: ZZHP1427BLK
• Catalog Number: ZZHP1427BLK
• Company Name: BOXOUT, LLC
• Labeler DUNS: 066689993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: a8b4dc4f-e7bf-47ab-bbbe-86c49c955347

Device Description

BodyMed Digital Heating Pad 14"x27", black cover

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRT	Pad, Heating, Powered	Physical Medicine	890.5740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11989	External electric-heating core temperature regulation system pad	An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20815802018719	GS1	Master carton	10	In Commercial Distribution
Primary	00815802018715	GS1
Package	10815802018712	GS1	Inner box	1	In Commercial Distribution

Customer Contacts

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