FDA.report

EMSRUN

Primary DI
06974567743448
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
PZSS0001
Published
2022-12-06
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
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications

CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974567743448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974567743448069745677434486974567743448

GMDN Terms

TermDefinition
Burn gelA substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
542972552
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06974567744704EMSRUNPZJD0020-22022-12-13
16974567747511RHINO RESCUECPDJ00052024-11-12
16974567747528RHINO RESCUECPHW00222024-10-24
16974567747771RHINO RESCUECP00252024-10-14
16974567747795RHINO RESCUECP00262024-10-14
16974567747535RHINO RESCUEPZZX00722024-10-12
06974567746630RHINO RESCUECPHW00022024-01-08
16974567748297Rhino RescuePZXF00012022-12-12
16974567749584Rhino RescueTJTK04022022-12-08
06974567749594Rhino RescueTJTK04072022-12-08
06974567749600Rhino RescueTJTK04062022-12-08
06974567749617Rhino RescueTJTK04052022-12-08
06974567749624Rhino RescueTJTK04042022-12-08
16974567749645Rhino RescueTJTK04032022-12-08
16974567749652Rhino RescueTJTK04012022-12-08
16974567749669Rhino RescueTJIK00062022-12-08
16974567749676Rhino RescueTJIK00052022-12-08
16974567749683Rhino RescueTJIK00042022-12-08
16974567749690Rhino RescueTJIK00032022-12-08
16974567749706Rhino RescueTJIK00022022-12-08

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