| Primary Device ID | 05030267157846 |
| NIH Device Record Key | a1ad1f08-5f48-47aa-b835-4d750b53a986 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 22MM SMOOTHBORE BILEVEL BREATHING SYSTEM SWIVEL CO2 LEAK PORT MONITORING LINE |
| Version Model Number | 5805031 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 00816472020435 - Filta-Therm™ HMEF with luer port, retainable cap and Flextube™ | 2025-02-11 Filta-Therm™ HMEF with luer port, retainable cap and Flextube™ |
| 00816472020558 - Breathing Circuit | 2025-02-11 Breathing Circuit, 22mm, nonconductive, single use, MRI Safe |
| 00816472020695 - Convenience Pack with 12" Flex Tube | 2025-02-11 Convenience Pack with 12" Flex Tube |
| 00816472021852 - Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line | 2025-02-11 Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line with universal connector tube, 1.8m |
| 00816472022217 - Smoothbore breathing system without exhalation port, 22mm, 1.6m | 2025-02-11 Smoothbore breathing system without exhalation port, 22mm, 1.6m |
| 00816472022538 - Multipac® Anesthesia Breathing System | 2025-02-11 Multipac® Anesthesia Breathing System |
| 00816472023610 - Smoothbore circuit, 22mm | 2025-02-11 Smoothbore circuit, 22mm |
| 00816472023696 - Multipac Anesthesia Breathing Circuit | 2025-02-11 Multipac Anesthesia Breathing Circuit |