Transfix Continence Sheath
- Primary DI
- 10801741072113
- Brand
- Transfix Continence Sheath
- Company
- C. R. Bard, Inc.
- Model
- TF12530
- Catalog number
- TF12530
- Device description
- Transfix All Silicone Self-Adhesive Continence Sheath
- Published
- 2020-09-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NNX | DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10801741072113 | Package | GS1 | 30 | In Commercial Distribution |
| 20801741072110 | Package | GS1 | 300 | In Commercial Distribution |
| 00801741072116 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10801741072113 | 10801741072113 | | |
| 20801741072110 | 20801741072110 | | |
| 00801741072116 | 00801741072116 | 801741072116 | 0801741072116 |
GMDN Terms
| Term | Definition |
|---|
| Urinary incontinence penis sheath/port, single-use, non-sterile | A non-sterile device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Outer Diameter | 25 | Millimeter |
Regulatory Flags
- DUNS number
- 016898496
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- 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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