This page includes the latest FDA filings for O2 Concepts L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3008910673 | 
| FEI Number | 3008910673 | 
| Name | O2 CONCEPTS, LLC | 
| Owner & Operator | O2 Concepts, LLC | 
| Contact Address | 199 Park Rd Ext Suite B Middlebury CT 06762 US  | 
| Official Correspondent | 
  | 
| Registration Status | 1 | 
| Initial Importer | N | 
| Registration Expiration | 2020-04-25 | 
| Registration Address | 199 Park Road Ext Ste B  Middlebury, CT 06762 US  | 
| Establishment Type | Manufacture Medical Device | 
Device Company  | Device | Date | 
|---|---|---|
|   O2 CONCEPTS, LLC  | Oxlife Liberty2 POC | 2024-05-21 | 
|   O2 CONCEPTS, LLC  | Oxlife Liberty POC | 2023-03-10 | 
|   O2 CONCEPTS, LLC  | Oxlife Freedom POC | 2019-04-23 | 
|   O2 CONCEPTS, LLC  | Oxlife Independence POC | 2019-02-18 | 
|   O2 CONCEPTS, LLC  | Oxlife Independence POC | 2019-02-18 | 
O2 CONCEPTS, LLC  | Oxlife Independence | 2019-02-13 | 
O2 Concepts LLC  | O2 Concepts Oxlife Independence Model 301-0001 | 2018-12-20 | 
| NCAGE Code | 6S0B3 | O2 CONCEPTS, LLC | 
| CAGE Code | 6S0B3 | O2 CONCEPTS, LLC | 
| S.A.M. Registration | 6S0B3 [34756852] | O2 CONCEPTS, LLC | 
| Import ID | Shipment | Cargo Description | Quantity | 
|---|---|---|---|
| 2019092410153 | Barcelona ,Spain -> New York, New York | MEDICAL SUPPLIES: PORTABLE CONCENTRATOR OXLIF | 25 PKG | 
| 2019091041565 | Barcelona ,Spain -> New York/Newark Area, Newark, New Jersey | MEDICAL SUPPLIES: PORTABLE CONCENTRATOR OXLIF | 1 PKG | 
| 2019010137096 | Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey | SLAC OXLIFE INDEPENDENCE POC FOR REPAIR LOADED ON 1 PALLET HS CODE:90192000 RETURN CARGO B8015724 | 14 PCS | 
| 2018091142055 | Barcelona ,Spain -> New York/Newark Area, Newark, New Jersey | MEDICAL SUPPLIES | 3 PKG | 
| 2018082412612 | Hong Kong,Hong Kong -> New York/Newark Area, Newark, New Jersey | (32CTNS PACKED INTO 4 PLASTIC PALLETS) TI231 PUMP ASSEMBLY PALLETS ID:R,S,T,U (H.S.CODE:8414 8080) | 32 CTN |