FDA.reportPublic FDA data

Ready-Heat

Primary DI
00850017905221
Brand
Ready-Heat
Company
TECHTRADE, LLC
Model
SB9RH9120
Device description
Ready-Heat Full Body Temperature Management Blanket
Published
2021-11-01
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
00850017905221PackageGS110In Commercial Distribution
00850017905054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017905221008500179052218500179052210850017905221
00850017905054008500179050548500179050540850017905054

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
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
16931918123400AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177564AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
16931918177984AllesetGRI Medical & Electronic Technology Co., Ltd.KME2024-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
16931918115214HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918121987HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918129372HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11
16931918149158HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11