AccessGUDID - DEVICE: Babson Hand Warmer (00850058457000)

GUDID

Device Identifier (DI) Information

Brand Name: Babson Hand Warmer
Version or Model: Babson Hand Warmer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WI-1-A3280020001
Company Name: Babson Diagnostics, Inc.

Primary DI Number: 00850058457000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059454260 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

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
Handling Environment Temperature: between 18 and 25 Degrees Celsius
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9b8b5456-bd79-4abd-943e-630df5a8926f
Public Version Date: February 13, 2024
Public Version Number: 2
DI Record Publish Date: January 12, 2024