FDA.reportPublic FDA data

Wellead Pump Hub and Tube

Primary DI
16936881167048
Brand
Wellead Pump Hub and Tube
Company
Well Lead Medical Co.,Ltd
Model
U10A040310
Device description
T-III
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
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936881167048PackageGS15In Commercial Distribution
26936881167045PackageGS110In Commercial Distribution
06936881167041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693688116704816936881167048
2693688116704526936881167045
06936881167041069368811670416936881167041

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). 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

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Primary DI, Brand, Company table
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34026704933373PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-08
34026704933380PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
24026704933406PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
10884450581008ReSolve®Merit Medical Systems, Inc.GBX2025-05-23
10661392032009LSL HEALTHCARELSL Industries, LLCGBX2025-05-16
10884450779900ReSolve®Merit Medical Systems, Inc.GBX2025-05-13
00840456205891JMUJMU DENTAL, INCGBX2025-05-02
24026704933345PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933352PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933413PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933468PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933472PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
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24026704933499PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933502PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933519PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933526PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933311PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933328PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933338PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933366PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933390PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933420PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933437PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933444PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933458PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
10884450719937ReSolve Mini™Merit Medical Systems, Inc.GBX2025-03-15