Cook
- Primary DI
- 00827002157392
- Brand
- Cook
- Company
- COOK INCORPORATED
- Model
- G15739
- Catalog number
- 020707-RM1
- Device description
- Urodynamics Catheter
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- Not 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 |
|---|---|
| FAP | CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00827002157392 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00827002157392 | 00827002157392 | 827002157392 | 0827002157392 |
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 |
|---|---|---|---|---|
| 18054655025986 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2025-02-24 |
| 18054655026006 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2025-02-24 |
| 18054655030386 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2025-02-24 |
| 18054655025979 | Urethral Catheter Electrode | SPES MEDICA SRL | FAP | 2021-05-24 |
| 18054655026013 | Urethral Catheter Electrode | SPES MEDICA SRL | FAP | 2021-05-24 |
| 08054655012897 | Spes Medica Pudendal Electrode | SPES MEDICA SRL | FAP | 2020-03-11 |
| 00827002156036 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158580 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158733 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158931 | Madduri | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158993 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002161696 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002167056 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002167803 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002168909 | Dewan | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002169876 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002170438 | Joseph | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002171749 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002172302 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002172524 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002172586 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002173187 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002152847 | Silber | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002154292 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002154346 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002154353 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002155404 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |