FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 04026704055166
·
Model: IPN052328
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- RUSCH
- Primary DI
- 04026704055166
- Version / Model
- IPN052328
- Catalog Number
- 410200-000180
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 47c3e362-5165-464a-88fc-a41f3dab1225
Device Description
Bladder catheter, Tiemann, 1 eye
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOD | CATHETER, UROLOGICAL | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42433 | Intermittent urethral drainage catheter, non-antimicrobial, reusable | A flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device is typically pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]; it does not include an antimicrobial agent(s). The device may be male or female dedicated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704055160 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04026704055166 | GS1 | ||||
| Package | 44026704055164 | GS1 | Carton | 42 | In Commercial Distribution | |
| Direct Marking | 14026704055163 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 18 | French |