Babson Hand Warmer

Basic Information

• Brand Name: Babson Hand Warmer
• Primary DI: 00850058457000
• Version / Model: Babson Hand Warmer
• Catalog Number: WI-1-A3280020001
• Company Name: Babson Diagnostics, Inc.
• Labeler DUNS: 059454260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-12
• Public Version: 2
• Public Version Date: 2024-02-13
• Public Version Status: Update
• Public Device Record Key: 9b8b5456-bd79-4abd-943e-630df5a8926f

Device Description

The Babson Hand Warmer is a powered heating device that provides heat to the palm of the hand to aid in blood collection. It is intended for use by a trained healthcare worker. It is capable of maintaining an elevated device temperature during use of the device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
67081	Capillary blood collection hand warmer	An electrically-powered heater intended to provide sustained heat (typically up to 42°C) to the palm of the hand of a patient to assist capillary blood collection from the fingertips. It is in the form of a small benchtop hand rest with a heated surface, on/off controls, and a finger-temperature sensor(s).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850058457000	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity