Cook
- Primary DI
- 00827002157453
- Brand
- Cook
- Company
- COOK INCORPORATED
- Model
- G15745
- Catalog number
- 050040-S8
- Device description
- Connecting Tube
- Published
- 2017-08-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FCN | Urinary drainage collection kit, for indwelling catheter |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00827002157453 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00827002157453 | 00827002157453 | 827002157453 | 0827002157453 |
GMDN Terms
| Term | Definition |
|---|
| Urethral/ureteral catheter connector, sterile | A small, sterile, connecting device intended to create a mechanical union between the proximal end of urethral and/or ureteral catheter and an external device (e.g., irrigation/vacuum unit, syringe, urine drainage bag) to enable infusion, drainage, or other procedures to be performed through the lumen of the catheter; it has no additional functions (e.g., not a two-way valve). It may also be intended to connect a urinary condom catheter (a penis sheath-type catheter) to a urine drainage bag. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dark, dry, cool place. |
Regulatory Flags
- DUNS number
- 042823948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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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