FDA.reportPublic FDA data

Burn Sheet, Sterile

Primary DI
00616784352039
Brand
Burn Sheet, Sterile
Company
DYNAREX CORPORATION
Model
3520
Device description
Burn Sheet, Sterile 60"x90"
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
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.

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

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
00616784352015Burn Sheet, Sterile Dynarex CorporationFBY2021-06-21
00616784353111Multi-Trauma DressingDynarex CorporationFBY2021-06-21
00616784353135Multi-Trauma DressingDYNAREX CORPORATIONFBY2021-06-21