| Primary Device ID | 00859758005030 |
| NIH Device Record Key | 5d435a7e-2c33-43d0-8483-c2cd708df6fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sontek Medical |
| Version Model Number | A1002 Case |
| Company DUNS | 072868941 |
| Company Name | NextPhase Medical Devices LLC |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859758005030 [Primary] |
| BZA | Connector, Airway (Extension) |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
[00859758005030]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-28 |
| Device Publish Date | 2025-02-20 |
| 10859758005020 | Bronch Safe™ Swivel Y |
| 10859758005006 | Suction Safe™ Swivel Y Inner pack |
| 00859758005061 | DHD Ported Swivel, Bulk |
| 00859758005054 | Suction Safe™ Swivel Y, Non-Sterile |
| 00859758005047 | Bronch Safe™ Swivel Y |
| 00859758005030 | Suction Safe™ Swivel Y Case |
| 00859758005023 | Bronch Safe™ Swivel Y |
| 00859758005009 | Suction Safe™ Swivel Y |