FDA.reportPublic FDA data

Sunbeam

Primary DI
00027045697408
Brand
Sunbeam
Company
Jarden Consumer Solutions
Model
000885-911-660U
Device description
Heating Pad
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10027045697405PackageGS16In Commercial Distribution
10027045743669PackageGS112In Commercial Distribution
10027045801567PackageGS112In Commercial Distribution
10270456974089PackageGS112In Commercial Distribution
40027045697406PackageGS112In Commercial Distribution
60027045697400PackageGS16In Commercial Distribution
00027045697408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002704569740510027045697405
1002704574366910027045743669
1002704580156710027045801567
1027045697408910270456974089
4002704569740640027045697406
6002704569740060027045697400
00027045697408000270456974080270456974080027045697408

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.

Regulatory Flags#

DUNS number
001315134
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00053891156219Sunbeam0538911562192021-02-25
00053891156226Sunbeam0538911562262021-02-25
00053891181952Sunbeam0538911819522025-12-03
00053891177184Sunbeam0538911771842024-09-10
00053891177207Sunbeam0538911772072024-09-10
00053891177221Sunbeam0538911772212024-09-10
00053891177245Sunbeam0538911772452024-09-10
30053891177185Sunbeam0538911771842024-09-10
30053891177208Sunbeam0538911772072024-09-10
30053891177222Sunbeam0538911772212024-09-10
30053891177246Sunbeam0538911772452024-09-10
00053891172073Sunbeam0538911720732023-10-12
30053891172074Sunbeam0538911720732023-10-12
00053891162692Sunbeam0538911626922023-04-12
30053891162693Sunbeam0538911626922023-04-12
00053891172066Sunbeam0538911720662023-03-13
30053891172067Sunbeam0538911720662023-03-13
00053891172172Sunbeam0538911721722022-11-15
00053891172189Sunbeam0538911721892022-11-15
00053891174015Sunbeam0538911740152022-11-15

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