Babson Hand Warmer WI-1-A3280020001

GUDID 00850058457000

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.

Babson Diagnostics, Inc.

Electric pad localized-body heating system
Primary Device ID00850058457000
NIH Device Record Key9b8b5456-bd79-4abd-943e-630df5a8926f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBabson Hand Warmer
Version Model NumberBabson Hand Warmer
Catalog NumberWI-1-A3280020001
Company DUNS059454260
Company NameBabson Diagnostics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com
Phone(512) 877-8770
Emailinfo@babsondx.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 18 Degrees Celsius and 25 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850058457000 [Primary]

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

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00850058457000 - Babson Hand Warmer2024-01-22The 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.
00850058457000 - Babson Hand Warmer2024-01-22 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
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