Cook
- Primary DI
- 00827002157644
- Brand
- Cook
- Company
- COOK INCORPORATED
- Model
- G15764
- Catalog number
- 026504-S2
- Device description
- Bladder Pressure Catheter
- Published
- 2016-09-24
- 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
Related Records
Contact Domains
cookmedical.comProduct Codes
| Code | Name |
|---|---|
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00827002157644 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00827002157644 | 00827002157644 | 827002157644 | 0827002157644 |
GMDN Terms
| Term | Definition |
|---|---|
| Urodynamic measurement system | An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dark, dry, cool place. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(812)330-5494 | sharedservices@cookmedical.com |
Regulatory Flags
- DUNS number
- 042823948
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00827002613508 | SureTome SW | G61350 | SUR-SW-35 | 2025-12-08 |
| 10827002613512 | SureTome SW | G61351 | SUR-SW-AWG2-35-260 | 2025-12-08 |
| 10827002613529 | SureTome SW | G61352 | SUR-SW-AWG2-35-450 | 2025-12-08 |
| 10827002242378 | Bakri | G24237 | J-SOSR-100500 | 2016-09-24 |
| 10827002306735 | Bakri | G30673 | J-SOS-100500 | 2016-09-24 |
| 00827002607842 | COOK | G60784 | TESLA-B2535-260 | 2025-07-22 |
| 00827002607859 | COOK | G60785 | TESLA-B2535-450 | 2025-07-22 |
| 10827002597508 | COOK | G59750 | TESLA-B-ACU | 2025-07-11 |
| 10827002496535 | Cotton-Leung Sof-Flex | G49653 | CLSO-SF-10-5 | 2015-11-03 |
| 00827002352674 | Hercules | G35267 | HBDE-W-8-9-10 | 2022-12-20 |
| 00827002352681 | Hercules | G35268 | HBDE-W-10-11-12 | 2022-12-20 |
| 00827002352698 | Hercules | G35269 | HBDE-W-12-13.5-15 | 2022-12-20 |
| 00827002352704 | Hercules | G35270 | HBDE-W-15-16.5-18 | 2022-12-20 |
| 00827002352711 | Hercules | G35271 | HBDE-W-18-19-20 | 2022-12-20 |
| 10827002346014 | Fusion | G34601 | FS-OMNI-ACRO-35-205 | 2016-09-24 |
| 10827002346939 | Fusion | G34693 | FS-OMNI-ACRO-35-260 | 2016-09-24 |
| 10827002347110 | Fusion | G34711 | FS-OMNI-ACRO-35-450 | 2016-09-24 |
| 10827002347783 | D.A.S.H. | G34778 | DASH-ACRO-35-450 | 2016-09-24 |
| 10827002347790 | D.A.S.H. | G34779 | DASH-ACRO-25-450 | 2016-09-24 |
| 10827002347806 | D.A.S.H. | G34780 | DASH-ACRO-35-260 | 2016-09-24 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 38032248471031 | Securmeter Foley Manometer | DELTA MED SPA | FEN | 2025-05-19 |
| 08720648846069 | PIM NXT for eSense | Laborie Medical Technologies Corp. | FEN | 2025-02-21 |
| 00627825013529 | e•Sense 7Fr Single Sensor Bladder Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 10627825013533 | e•Sense 7Fr Single Sensor Coudé Bladder Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 10627825013540 | e•Sense 7Fr Dual Sensor Urethral Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 00627825013550 | e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 00627825013567 | e•Sense 7Fr Abdominal Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 20627825014841 | T-DOC 5Fr Air-Charged Abdominal Sensor Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 20627825014858 | T-DOC 5Fr Air-Charged Single Sensor Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 20627825014865 | T-DOC 5Fr Air-Charged Single Sensor Catheter | Laborie Medical Technologies Corp. | FEN | 2024-12-12 |
| 08594211570466 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570473 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570480 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570497 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570541 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570558 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570565 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570572 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570664 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570671 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570688 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570695 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570701 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570718 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570725 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570732 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570824 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570831 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570848 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |
| 08594211570855 | ATMOS Air-Charged Pressure Sensor | MEDKONSULT medical technology s.r.o. | FEN | 2024-11-06 |