Vitalcontrol

Basic Information

• Brand Name: Vitalcontrol
• Primary DI: 00850031772014
• Version / Model: SHK22 (Red)
• Company Name: BEURER NORTH AMERICA, L.P.
• Labeler DUNS: 078497467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-31
• Public Version: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 5e54b30c-d683-4c8f-a913-3b1551813a6b

Device Description

IAN 366501_2101 Heating Pad (Red) SHK 22 Art. No 211.58/ EAN 4211125211585 Art. No 211.68/ EAN 4211125211790

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: No
• Has Lot/Batch Number: Yes
• 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
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850031772011	GS1	Inner pack	6	In Commercial Distribution
Primary	00850031772014	GS1

Customer Contacts

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