FDA.report

EMSRUN

Primary DI
06974567741123
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
PZFZ0001
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications

CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06974567741123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06974567741123069745677411236974567741123

GMDN Terms

TermDefinition
Secretion/excreta skin cleanserA non-sterile substance typically used by ostomists or incontinent persons to gently cleanse skin exposed to intestinal secretions (e.g., around a stoma or fistula) or to excreta (urine or faeces). It is typically used to replace cleaning with soap and water which can aggravate the skin causing soreness/inflammation; it may also be used to remove small amounts of adhesive residue or barrier creams. The device is provided in a variety of forms including a solution, sachets, or disposable wipes. After application, this device cannot be reused.

Sterilization Methods

Method
High Intensity Light or Pulse Light

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
true

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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