FDA.reportPublic FDA data

Burn Sheet, Sterile

Primary DI
00616784352015
Brand
Burn Sheet, Sterile
Company
Dynarex Corporation
Model
3520
Device description
"Burn Sheet, Sterile 60""x90"""
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FBYCooler, Esophageal And Gastric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBYCooler, Esophageal And GastricUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784352039PackageGS112In Commercial Distribution
00616784352015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784352039006167843520396167843520390616784352039
00616784352015006167843520156167843520150616784352015

GMDN Terms#

Term, Definition table
TermDefinition
Fire blanketA large piece of fabric material specially designed for wrapping around a person or an object for either protection from fire or to extinguish the flames if the person/object is on fire. This device is manufactured with a certain degree of fire resistance to inhibit its spread and is typically available in a container that can be placed at strategic points in a building.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117308558Resp-O2 Aerosol Standard Adult Mask340002021-04-22
00840117308572Resp-O2 Aerosol Elongated Masks, Adult340032021-04-22
00840117308619Resp-O2 Small Volume Nebulizer 6 cc Cup341042021-04-22
00840117308633Resp-O2 Small Volume Nebulizer 6cc Cup341052021-04-22
00840117308657Resp-O2 Small Volume Nebulizer 6 cc Cup341202021-04-22
00840117311732Resp-O2 Aerosol Standard Mask, Pediatric340012021-04-22
00840117311770Resp-O2 Aerosol Elongated Masks, Pediatric340042021-04-22
00840117311794Resp-O2 Aerosol Face Tent Mask, Adult340052021-04-22
00840117311817Resp-O2 Small Volume Nebulizer341002021-04-22
00840117311831Resp-O2 Small Volume Nebulizer 6 cc Cup341012021-04-22
00840117311855Resp-O2 Small Volume Nebulizer 6 cc Cup341022021-04-22
00840117311879Resp-O2 Small Volume Nebulizer 6 cc Cup341032021-04-22
00840117311893Resp-O2 Small Volume Nebulizer 6 cc Cup341062021-04-22
00840117311916Resp-O2 Small Volume Pacifier Nebulizer Kit341072021-04-22
00840117318007Resp-O2 Tracheostomy Adult Mask340212021-04-22
00840117318014Resp-O2 Tracheostomy Pediatric Mask340222021-04-22
00840117318069Resp-O2 Tracheostomy Adult Mask340202021-04-22
00840117311756Resp-O2 Aerosol Standard Mask, Infant340022021-01-19
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616784353111Multi-Trauma DressingDynarex CorporationFBY2021-06-21
00616784352039Burn Sheet, Sterile DYNAREX CORPORATIONFBY2021-06-21
00616784353135Multi-Trauma DressingDYNAREX CORPORATIONFBY2021-06-21