FDA.reportPublic FDA data

Ready-Heat

Primary DI
00850017905061
Brand
Ready-Heat
Company
TECHTRADE, LLC
Model
SB6RH9120
Device description
Ready-Heat Half Body Temperature Management Blanket
Published
2022-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017905184PackageGS120In Commercial Distribution
00850017905061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017905184008500179051848500179051840850017905184
00850017905061008500179050618500179050610850017905061

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, single-useA non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
866-491-8324info@ready-heat.com

Regulatory Flags#

DUNS number
169940405
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017905009Ready-HeatS1RHSM2022-10-26
00850017905016Ready-HeatS4RHMD2021-11-01
00850017905023Ready-HeatS6RHLG2021-11-01
00850017905030Ready-HeatG12RH22021-11-01
00850017905047Ready-HeatG6RH2T2022-10-26
00850017905054Ready-HeatSB9RH91202021-11-01
00850017905078Ready-HeatS2RHIM2022-10-26
00850017905085Ready-HeatGIW6C2022-04-29
00850017905108Ready-HeatGRHV06A2022-04-29
00850017905238NAR by Ready-HeatS4RHMD-N2021-12-15
00850017905252Ready-HeatED9RH2023-06-27
00850017905139Ready-HeatS1RHSM2022-10-26
00850017905160Ready-HeatG6RH2T2022-10-26
00850017905207Ready-HeatS2RHIM2022-10-26
00850017905184Ready-HeatSB6RH91202022-04-29
00850017905191Ready-HeatGIW6C2022-04-29
00850017905146Ready-HeatGRHV06A2022-04-29
00850017905245NAR by Ready-HeatS4RHMD-N2021-12-15
00850017905115Ready-HeatS4RHMD2021-11-01
00850017905122Ready-HeatS6RHLG2021-11-01

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Primary DI, Brand, Company table
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00841445001449Diva Hot Flash PatchDiva International IncIMD2026-10-12
06941917859852HuayilangShandong Zhushi Pharmaceutical Group Co., Ltd. First OfficeIMD2026-10-11
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04260647540321TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
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04260647540369TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
00199972000535CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000559CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00845819082003Oasis REST & RELIEF Single-UseOASIS MEDICAL, INC.IMD2026-08-14
00845819083000Oasis REST & RELIEF Plus Single-UseOASIS MEDICAL, INC.IMD2026-08-14
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 228Dynarex CorporationKME2026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
10080196158652MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.IMD2026-07-16
00808829131321Lucky Super SoftDELTA BRANDS INC.IMD2026-07-10
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15