FDA.reportPublic FDA data

THERA Plus

Primary DI
00049696507806
Brand
THERA Plus
Company
FOURSTAR GROUP INC.
Model
64430168BA
Device description
TP THERAPY ICE BAG
Published
2023-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYRBag, Ice

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYRBag, IceGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00049696507806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00049696507806000496965078060496965078060049696507806

GMDN Terms#

Term, Definition table
TermDefinition
Ice bagA flexible container (a bag) designed to be filled with ice to provide dry cold therapy to a limited external surface area of the body. It is typically made of plastic or rubber materials with a detachable cap that can be threaded or fixed to the bag once it is filled with ice. It may include a holder or attachments to facilitate fixing or holding the device in place against the body surface of the patient. It can be used to alleviate pain and/or promote healing in minor injuries of the body, e.g., after minor surgery, bruises, tissue swelling, or for application around the neck or limbs. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656091279
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00049696189583THERA Plus644101842026-06-09
00049696198189B.PURE644103382026-06-09
00049696295260THERA Plus644103662026-06-09
00049696295277THERA Plus644103662026-06-09
00049696295284THERA Plus644103662026-06-09
00049696295291THERA Plus644103662026-06-09
00049696295307THERA Plus644103662026-06-09
00049696295314THERA Plus644103662026-06-09
00049696508339THERA Plus64409658V2026-06-09
00049696508346B.PURE64409346B2026-06-09
00049696508360THERA Plus64409535A2026-06-09
00049696508377THERA Plus64409535B2026-06-09
00049696508384THERA Plus64409535C2026-06-09
00049696561228THERA Plus644103222026-06-09
00049696561518B.PURE644103252026-06-09
00049696562102B.PURE644103262026-06-09
00049696677547THERA Plus644103832026-06-09
00049696712194B.PURE644102892026-06-09
00049696898232B.PURE64410005D2026-06-09
00050428284537CVSHealth64408659Y2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612606001642KERMACardinal Health 200, LLCKYR2026-01-29
10612606001649KERMACardinal Health 200, LLCKYR2026-01-29
00885914108062Sammons Preston Performance Health Supply, LLCKYR2026-01-23
00885914108079Sammons PrestonPerformance Health Supply, LLCKYR2026-01-23
10860001416715Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416722Denta-CoolCHEMOMOUTHPIECE, LLCKYR2024-05-22
10860001416739Chemo MouthpieceCHEMOMOUTHPIECE, LLCKYR2024-05-22
00683534040010A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040027A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
00683534040034A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040016A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040023A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
80683534040030A PlusA PLUS INTERNATIONAL INC.KYR2024-01-18
M20890046941CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046951CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046942CUSTOMEDCUSTOMED INCKYR2023-08-10
M20890046952CUSTOMEDCUSTOMED INCKYR2023-08-10
00810132040061HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00810132040078HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040068HCSConcordance Healthcare Solutions LLCKYR2023-05-19
10810132040075HCSConcordance Healthcare Solutions LLCKYR2023-05-19
00057475570095BIOS LivingThermor LtdKYR2023-03-31
10057475570092BIOS LivingThermor LtdKYR2023-03-31
06975306620013Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620020magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620037magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620044magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620051magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306620068magicgelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25
06975306622024Magic gelAnhui Kamt Ice Pack Co.,Ltd.KYR2022-10-25