FDA UDI
In Commercial Distribution
🇺🇸 United States
O'Neil Intermittent Urinary Catheter
DI: 09350902001201
·
Model: 14 Gauge
·
GO MEDICAL INDUSTRIES PTY. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- O'Neil Intermittent Urinary Catheter
- Primary DI
- 09350902001201
- Version / Model
- 14 Gauge
- Catalog Number
- ONSM14
- Company Name
- GO MEDICAL INDUSTRIES PTY. LTD.
- Labeler DUNS
- 757634266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-17
- Public Version
- 4
- Public Version Date
- 2023-03-27
- Public Version Status
- Update
- Public Device Record Key
- 6872c9e7-1427-457b-a322-1d9dc3c4fa03
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GBM | Catheter, Urethral | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47778 | Intermittent urethral catheterization kit | A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09350902001218 | GS1 | Carton | 200 | In Commercial Distribution | |
| Primary | 09350902001201 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993651 | 000 |