FDA UDI
In Commercial Distribution
🇺🇸 United States
Wellead Male External Catheter
DI: 06944932730748
·
Model: F03A033610
·
Well Lead Medical Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Wellead Male External Catheter
- Primary DI
- 06944932730748
- Version / Model
- F03A033610
- Company Name
- Well Lead Medical Co.,Ltd
- Labeler DUNS
- 544811862
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-10
- Public Version
- 1
- Public Version Date
- 2023-07-18
- Public Version Status
- New
- Public Device Record Key
- 93adfbcc-0f1f-4dca-8a71-b41de74b7789
Device Description
Type III 36mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXJ | Device, Incontinence, Urosheath Type, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61504 | Penis wearable urinal | An externally-worn urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag. The device is intended to provide an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention, and eliminates the need for groin and waist straps. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16944932730745 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 06944932730748 | GS1 | ||||
| Package | 26944932730742 | GS1 | Carton | 10 | In Commercial Distribution |