FDA.reportPublic FDA data

Babson Hand Warmer

Primary DI
00850058457000
Brand
Babson Hand Warmer
Company
Babson Diagnostics, Inc.
Model
Babson Hand Warmer
Catalog number
WI-1-A3280020001
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.
Published
2024-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850058457000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058457000008500584570008500584570000850058457000

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(512) 877-8770info@babsondx.com

Regulatory Flags#

DUNS number
059454260
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058457048BD MiniDraw Capillary Tube Adapter H&H366619-10366619-102025-12-09
00850058457055BD MiniDraw Finger Sizing Tool366617-100366617-1002025-12-09
00850058457031BD MiniDraw Capillary Tube Adapter SST366620-10366620-102025-12-09
00382903666171BD MiniDraw Finger Sizing Tool366617-100366617-1002025-12-09
00850058457017Babson Sample Preparation DeviceBabson Sample Preparation DeviceSE-9-020012024-05-13

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