FDA.report

Wellead PVC Hydrophilic Urethral Catheter

Primary DI
16936881163545
Brand
Wellead PVC Hydrophilic Urethral Catheter
Company
Well Lead Medical Co.,Ltd
Model
F01J030810
Device description
with water sachet Female Pediatric 8Fr(2.7mm)
Published
2023-11-06
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

Related Records

Product Codes

CodeName
EZDCatheter, Straight

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K220722000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K220722000PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.2023-05-22EZD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16936881163545PackageGS130In Commercial Distribution
26936881163542PackageGS110In Commercial Distribution
06936881163548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693688116354516936881163545
2693688116354226936881163542
06936881163548069368811635486936881163548

GMDN Terms

TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
544811862
Device count
1
DM exempt
false
Premarket exempt
false
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

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