FDA.reportPublic FDA data

Wellead Urodynamic Catheter

Primary DI
16936881133463
Brand
Wellead Urodynamic Catheter
Company
Well Lead Medical Co.,Ltd
Model
U08A010710
Device description
Double-lumen 7Fr
Published
2023-07-12
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
true

Product Codes#

Code, Name table
CodeName
FENDevice, Cystometric, Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936881133463PackageGS110In Commercial Distribution
26936881133460PackageGS110In Commercial Distribution
06936881133466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693688113346316936881133463
2693688113346026936881133460
06936881133466069368811334666936881133466

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic manometric catheter, non-electronicA sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device.

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
16925816667210ClearPetraU04A1010262026-03-16
16925816667227ClearPetraU04A1011262026-03-16
16925816667234ClearPetraU04A1012262026-03-16
16925816657518ClearPetraU04A1010262026-01-26
16925816657525ClearPetraU04A1011262026-01-26
16925816657532ClearPetraU04A1012262026-01-26
16925816657549ClearPetraU04A1013262026-01-26
16925816657556ClearPetraU04A1010362026-01-26
16925816657563ClearPetraU04A1011362026-01-26
16925816657570ClearPetraU04A1012362026-01-26
16925816657587ClearPetraU04A1013362026-01-26
16925816657594ClearPetraU04A1010402026-01-26
16925816657600ClearPetraU04A1011402026-01-26
16925816657617ClearPetraU04A1012402026-01-26
16925816657624ClearPetraU04A1013402026-01-26
16925816657631ClearPetraU04A1010462026-01-26
16925816657648ClearPetraU04A1011462026-01-26
16925816657655ClearPetraU04A1012462026-01-26
16925816657662ClearPetraU04A1013462026-01-26
16925816657679ClearPetraU04A1010502026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38032248471031Securmeter Foley ManometerDELTA MED SPAFEN2025-05-19
08720648846069PIM NXT for eSenseLaborie Medical Technologies Corp.FEN2025-02-21
00627825013529e•Sense 7Fr Single Sensor Bladder CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825013533e•Sense 7Fr Single Sensor Coudé Bladder CatheterLaborie Medical Technologies Corp.FEN2024-12-12
10627825013540e•Sense 7Fr Dual Sensor Urethral CatheterLaborie Medical Technologies Corp.FEN2024-12-12
00627825013550e•Sense 7Fr Dual Sensor Coudé Uretheral CatheterLaborie Medical Technologies Corp.FEN2024-12-12
00627825013567e•Sense 7Fr Abdominal CatheterLaborie Medical Technologies Corp.FEN2024-12-12
20627825014841T-DOC 5Fr Air-Charged Abdominal Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
20627825014858T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
20627825014865T-DOC 5Fr Air-Charged Single Sensor CatheterLaborie Medical Technologies Corp.FEN2024-12-12
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