FDA.reportPublic FDA data

MedSource Burn Sheet

Primary DI
00840155400696
Brand
MedSource Burn Sheet
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-BS0033
Catalog number
Not Applicable
Device description
Burn Sheet
Published
2021-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPYSheet, Burn

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPYSheet, BurnGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840155400696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155400696008401554006968401554006960840155400696

GMDN Terms#

Term, Definition table
TermDefinition
Cotton burn sheetA sterile covering designed to treat large to massive patient burns. It is made of woven cotton impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, provide pain relief, moisten and cool the burn area, and prevent burn progression. It is available in various sizes [e.g., towel to blanket (sheet)] and may also be used to smother small flames. It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041674552
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03
00840155404540MedSource BagsMS-B33655FPNot Applicable2021-07-28
00840155404670MedSource BagsMS-B3362Not Applicable2021-07-28
00840155407411MedSource BagsMS-B3350RNot Applicable2021-07-28
00840155406667MedSource BagsMS-B3309Not Applicable2021-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196756544MEDLINEMEDLINE INDUSTRIES, INC.FPY2025-10-22
20197344112262MEDLINEMEDLINE INDUSTRIES, INC.FPY2024-11-08
10197344112265MEDLINEMEDLINE INDUSTRIES, INC.FPY2024-11-08
00743537000067First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000074First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000081First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000128First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000135First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000166First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000197First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000203First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537001439First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000029MilitaryWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000036First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000043First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000517First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000111MilitaryWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000531First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000548First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000555First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000050BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-19
00743537000005BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-17
00743537000012BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-17
10850053289528SURGYCOSurgyco LLCFPY2024-08-09
10850053289597SURGYCOSurgyco LLCFPY2024-08-09
10850053289603SURGYCOSurgyco LLCFPY2024-08-09
10850053289610SURGYCOSurgyco LLCFPY2024-08-09
00850053289521SURGYCOSurgyco LLCFPY2024-08-09
00850053289590SURGYCOSurgyco LLCFPY2024-08-09
00850053289606SURGYCOSurgyco LLCFPY2024-08-09