FDA.reportPublic FDA data

THERMAWRAP ADULT HEAD COVER

Primary DI
05059443003579
Brand
THERMAWRAP ADULT HEAD COVER
Company
ARMSTRONG MEDICAL LTD
Model
AMTW1000
Published
2023-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05059443003579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05059443003579050594430035795059443003579

GMDN Terms#

Term, Definition table
TermDefinition
Hypothermia-prevention capA head covering in the form of a cap intended to be worn by a patient typically during conditions of low body temperature and/or long surgical procedures to minimize loss of body heat from the head. It typically includes a heat-reflecting inner metal surface to facilitate retention of body heat. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442870356029reception@armstrongmedical.net

Regulatory Flags#

DUNS number
239659915
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060505643701AMSORB® PLUSAMAB3801GE2021-08-18
05060505643718AMSORB® PLUSAMAB3201GE2021-08-18
05060505643725AMSORB® PLUSAMAB3803GE2021-08-18
15059443000001AMSORB® PLUSAMAB30002021-08-18
15059443000018AMSORB® PLUSAMAB32002021-08-18
15059443000025AMSORB® PLUSAMAB32012021-08-18
15059443000032AMSORB® PLUSAMAB34002021-08-18
15059443000049AMSORB® PLUSAMAB38002021-08-18
15059443000056AMSORB® PLUSAMAB38012021-08-18
15059443000070AMSORB® PLUSAMAB38032021-08-18
15059443000087AMSORB® PLUSAMAB40012021-08-18
15059443014466AMSORB® PLUSAMAB4001GE2021-08-18
05060505643732AMSORB® PLUSAMAB3000GE2021-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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