| Primary Device ID | 00888937027853 |
| NIH Device Record Key | 2cfaf2ed-47c2-4a08-9d82-a0baec949073 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bakri® |
| Version Model Number | J-SOS-100500 |
| Company DUNS | 801895244 |
| Company Name | Coopersurgical, Inc. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888937027853 [Primary] |
| OQY | Intrauterine Tamponade Balloon |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-18 |
| Device Publish Date | 2025-12-10 |
| 00888937027853 | Bakri® Postpartum Balloon |
| 00888937027846 | Bakri® Postpartum Balloon with Rapid Instillation Components |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BAKRI 85292658 4152740 Live/Registered |
Cook Medical Technologies LLC 2011-04-12 |