FDA.reportPublic FDA data

Ready-Heat

Primary DI
00850017905139
Brand
Ready-Heat
Company
TECHTRADE, LLC
Model
S1RHSM
Device description
Ready-Heat 1 Panel Warming Wrap
Published
2022-10-26
Public version status
New
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
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017905139PackageGS112In Commercial Distribution
00850017905009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017905139008500179051398500179051390850017905139
00850017905009008500179050098500179050090850017905009

GMDN Terms#

Term, Definition table
TermDefinition
Bed blanket, single-useA large piece of fabric or fabric-like material used to cover a patient/person to insulate body heat for warmth. It is typically used as a bed covering, but may be used for other purposes (e.g., as a wrap for warmth and comfort). This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
169940405
Device count
1
DM exempt
false
Premarket exempt
true
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
00850017905061Ready-HeatSB6RH91202022-04-29
00850017905078Ready-HeatS2RHIM2022-10-26
00850017905085Ready-HeatGIW6C2022-04-29
00850017905108Ready-HeatGRHV06A2022-04-29
00850017905238NAR by Ready-HeatS4RHMD-N2021-12-15
00850017905252Ready-HeatED9RH2023-06-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
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07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
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10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08