FDA.reportPublic FDA data

Emergency Survival Rescue Blanket

Primary DI
00616784353715
Brand
Emergency Survival Rescue Blanket
Company
Dynarex Corporation
Model
3537
Device description
"Emergency Survival Rescue Blanket, 84""x52"""
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00616784353739PackageGS1120In Commercial Distribution
00616784353715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784353739006167843537396167843537390616784353739
00616784353715006167843537156167843537150616784353715

GMDN Terms#

Term, Definition table
TermDefinition
Rescue blanket, reusableA large thin sheet of material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation; it may additionally be intended to be used by a patient prior to surgery. It is designed as a flat whole-body wrap, blanket or poncho, and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. It is typically used by emergency medical services (EMS); it is not intended for carrying/transporting a patient [it is not a rescue bag]. This is a reusable device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
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