FDA.report

Emergency Survival Rescue Blanket

Primary DI
00616784353739
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KMEBedding, Disposable, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784353739PackageGS1120In Commercial Distribution
00616784353715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784353739006167843537396167843537390616784353739
00616784353715006167843537156167843537150616784353715

GMDN Terms

TermDefinition
Rescue blanketA large piece of fabric material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation. It is typically used by emergency medical services (EMS) and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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