FDA.reportPublic FDA data

Thermoflect

Primary DI
10612899004372
Brand
Thermoflect
Company
Encompass Group, L.L.C.
Model
5100-700-DOD
Device description
THERMOFLECT BLANKET, L, 25EA TS THERMOFLECT BLANKET, 48" X 84", GREEN, 1/BG, 25 BG/CS NW
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
10612899004372PackageGS125In Commercial Distribution
00612899004375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061289900437210612899004372
00612899004375006128990043756128990043750612899004375

GMDN Terms#

Term, Definition table
TermDefinition
Hypothermia-prevention whole-body suitA full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-284-4540compliance@encompassgroup.net

Regulatory Flags#

DUNS number
121788819
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
false
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
00612899045484EncompassVA550-252023-06-22
00612899101104EncompassVA550-25XB2023-06-22
20612899002726EncompassTP1002023-06-22
20612899004713EncompassG-P91532023-06-22
20612899004720EncompassG-P9163A2023-06-22
20612899005574EncompassG-P91642023-06-22
20612899005581EncompassG-P9165A2023-06-22
20612899005598EncompassG-P91662023-06-22
20612899005604EncompassG-P91512023-06-22
20612899005611EncompassG-P91522023-06-22
20612899005628EncompassG-P91542023-06-22
20612899005635EncompassG-P91552023-06-22
20612899005642EncompassG-P91562023-06-22
20612899005659EncompassG-P9161A2023-06-22
20612899005666EncompassG-P9162A2023-06-22
20612899005673EncompassG-P91642023-06-22
20612899005680EncompassP9165A2023-06-22
20612899005697EncompassP91662023-06-22
20612899005826EncompassG-P91502023-06-22
20612899005864EncompassG-P91602023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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