FDA.reportPublic FDA data

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

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 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 table
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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00840117305717Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310102021-04-22
00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305779Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310212021-04-22
00840117305786Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult310222021-04-22
00840117305809Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310322021-04-22
00840117318144Resp-O2 Closed Suction Endotracheal Catheters, Sterile310202021-04-22
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00840117319462Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310032021-04-22
00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319523Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310332021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
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00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310342026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310352026-05-18

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