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
00049696561228THERA Plus644103222026-06-09
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
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
00843776101843Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101850Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101867Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101874Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101881Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101898Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101904Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101911Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101928Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101935Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101942Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101959Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101966Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101973Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101980Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776101997Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102000Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102017Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102024Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102031Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102628Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102635Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102642Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102659Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102666Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102673Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102895Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102901Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102918Neotech CareNEOTECH CARE INC.KYR2026-07-23
00843776102925Neotech CareNEOTECH CARE INC.KYR2026-07-23