| Primary Device ID | 10884521836952 |
| NIH Device Record Key | 9c8670ff-9751-48d4-9093-ebea00d957ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newport |
| Version Model Number | BCS12820P |
| Company DUNS | 050334275 |
| Company Name | Newport Medical Instruments, Inc. |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521836952 [Primary] |
| CAI | Circuit, breathing (w connector, adaptor, y piece) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
[10884521836952]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-10 |
| Device Publish Date | 2023-03-02 |
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| 10884521541115 | e360 Ventilator with Accessories;S Model |
| 10884521541085 | e360 Ventilator with Accessories;S Model |
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| 10884521540927 | e360 Ventilator with Accessories;E Model |
| 10884521541139 | e360 Ventilator with Accessories;S Model |
| 10884521510821 | e360 Ventilator with Accessories T Model |
| 10884521212183 | e360 Ventilator with Accessories S Model |
| 10884521510845 | e360 Ventilator with Accessories T Model |
| 10884521542259 | HT70 Ventilator With Accessories;Plus Model |
| 10884521541245 | e360 Ventilator with Accessories;T Model |
| 10884521510760 | e360 Ventilator with Accessories S Model |
| 10884521542143 | HT70 Ventilator With Accessories;O2 Monitor |
| 10884521544062 | HT70 Ventilator with Accessories O2 Monitor |
| 10884521544345 | HT70 Ventilator with Accessories |
| 10884521542211 | HT70 Ventilator With Accessories;Plus Model |
| 10884521541269 | e360 Ventilator with Accessories;T Model |
| 10884521541252 | e360T VENTILATOR, T MODEL US, HEAD ONLY NA POWER |
| 10884521541214 | e360 Ventilator with Accessories;T Model |
| 10884521541184 | e360 Ventilator with Accessories;T Model |
| 10884521541146 | e360 Ventilator with Accessories;S Model |
| 10884521541122 | e360 Ventilator with Accessories;S Model |
| 10884521541023 | e360 VENTILATOR, SPANISH PLUS |
| 10884521510784 | E360T VENT, TS HEAD ONLY,SPAN |
| 10884521510623 | E360T VENT,TS HEAD ONLY, CHIN |
| 10884521510593 | E360T1 VENTILATOR BRAZIL, EXPANDED TOUCH HEAD ONLY |
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| 10884521544369 | HT70 Ventilator with Accessories Plus Model |
| 10884521544321 | HT70 Ventilator with Accessories Plus Model |
| 10884521542228 | HT70 Ventilator With Accessories;Plus Model |
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| 10884521510869 | e360 Ventilator with Accessories T Model |
| 10884521511279 | e360 Ventilator with Accessories E Model |
| 10884521544413 | HT70 Ventilator with Accessories Plus Model |
| 10884521542266 | HT70 Ventilator With Accessories Plus Model |
| 10884521542242 | HT70 Ventilator With Accessories Plus Model |
| 10884521542235 | HT70 Ventilator With Accessories Plus Model |
| 10884521542204 | HT70 Ventilator With Accessories Plus Model |
| 10884521542181 | HT70 Ventilator With Accessories Plus Model |
| 10884521542174 | HT70 Ventilator With Accessories Plus Model |
| 10884521511774 | e360 Ventilator with Accessories T Model |
| 10884521208940 | HT70PLUS VENT,ENGLISH,NA CORDD, D/L |
| 10884521541283 | e360 Ventilator with Accessories;T Model |
| 10884521541009 | e360 Ventilator with Accessories;E Model |