| Primary Device ID | 00840253112200 |
| NIH Device Record Key | 16f13ede-b867-4169-ab1b-efe67343cf9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydra® |
| Version Model Number | SIT-355 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 15 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-632-3636 |
| [email protected] |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816849016948 [Unit of Use] |
| GS1 | 00840253112200 [Primary] |
| FEQ | Pump, Air, Non-Manual, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2017-06-29 |
| 00816849019895 | Water Jet Connector |
| 00816849019864 | Water bottle cap, sterile |
| 00816849019833 | Water bottle cap with CO2, sterile |
| 00816849016955 | Water Jet Connector |
| 00816849016894 | Water bottle cap with CO2, sterile |
| 00816849016887 | Water bottle cap, sterile |
| 00840253112200 | Irrigation water bottle cap tubing |
| 00840253108531 | Water bottle cap with CO2, sterile |
| 00840253108487 | Water bottle cap with CO2, sterile |
| 00840253108456 | Irrigation water bottle cap tubing |
| 00840253108425 | Irrigation water bottle cap tubing |
| 00840253108401 | Irrigation water bottle cap tubing |