FDA.reportPublic FDA data

Wellead Portable Roller Irrigation Pump

Primary DI
16936881166980
Brand
Wellead Portable Roller Irrigation Pump
Company
Well Lead Medical Co.,Ltd
Model
U10A010110
Device description
WP-I-01, T-I
Published
2023-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936881166980PackageGS11In Commercial Distribution
26936881166987PackageGS11In Commercial Distribution
06936881166983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693688116698016936881166980
2693688116698726936881166987
06936881166983069368811669836936881166983

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation pumpAn electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544811862
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925816673962Wellead Hydrophilic Intermittent Catheter F01L0308302026-04-03
06925816673979Wellead Hydrophilic Intermittent Catheter F01L0310302026-04-03
06925816673986Wellead Hydrophilic Intermittent Catheter F01L0312302026-04-03
06925816673993Wellead Hydrophilic Intermittent Catheter F01L0314302026-04-03
06925816674006Wellead Hydrophilic Intermittent Catheter F01L0316302026-04-03
06925816674013Wellead Hydrophilic Intermittent Catheter F01L0318302026-04-03
06925816674020Wellead Hydrophilic Intermittent Catheter F01L0208202026-04-03
06925816674037Wellead Hydrophilic Intermittent Catheter F01L0210202026-04-03
06925816674044Wellead Hydrophilic Intermittent Catheter F01L0212202026-04-03
06925816674051Wellead Hydrophilic Intermittent Catheter F01L0214202026-04-03
06925816674068Wellead Hydrophilic Intermittent Catheter F01L0216202026-04-03
06925816674075Wellead Hydrophilic Intermittent Catheter F01L0218202026-04-03
06925816674082Wellead Hydrophilic Intermittent Catheter F01L0410302026-04-03
06925816674099Wellead Hydrophilic Intermittent Catheter F01L0412302026-04-03
06925816674105Wellead Hydrophilic Intermittent Catheter F01L0414302026-04-03
06925816674112Wellead Hydrophilic Intermittent Catheter F01L0416302026-04-03
06925816674129Wellead Hydrophilic Intermittent Catheter F01L0418302026-04-03
06925816674136Wellead Hydrophilic Intermittent Catheter F01L0108102026-04-03
06925816674143Wellead Hydrophilic Intermittent Catheter F01L0110102026-04-03
06925816674150Wellead Hydrophilic Intermittent Catheter F01L0112102026-04-03

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