Bakri J-SOS-100500-V
GUDID 10827002590943
Bakri Essential Postpartum Balloon
COOK INCORPORATED
Intrauterine haemostatic balloon catheter| Primary Device ID | 10827002590943 |
| NIH Device Record Key | ad1e513d-3c7c-4cca-99ab-d064491debc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bakri |
| Version Model Number | G59094 |
| Catalog Number | J-SOS-100500-V |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002590946 [Primary] |
| GS1 | 10827002590943 [Package] Contains: 00827002590946 Package: EA [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223098
FDA Product Code
| OQY | Intrauterine tamponade balloon |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-08 |
| Device Publish Date | 2023-02-28 |
Devices Manufactured by COOK INCORPORATED
| 00827002352674 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352681 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352698 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352704 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352711 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 10827002346014 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002346939 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002347110 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
Trademark Results [Bakri]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BAKRI 85292658 4152740 Live/Registered |
Cook Medical Technologies LLC 2011-04-12 |
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