| Primary Device ID | 00853041003000 |
| NIH Device Record Key | bb1a45b8-396f-47fa-a662-bbe3e340981e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3B Medical Aer |
| Version Model Number | Aer X |
| Catalog Number | 021000M |
| Company DUNS | 078517316 |
| Company Name | 3B MEDICAL, INC. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853041003000 [Primary] |
| CAW | Generator, Oxygen, Portable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2019-08-13 |
| 00860006339906 - Lumin | 2021-02-09 Lumin serves as both a general-purpose sanitizing device for personal care items (e.g. cell phone, eyeglasses, keys, etc.) as we |
| 00853041003000 - 3B Medical Aer | 2019-08-21Aer X is a portable Oxygen concentrator |
| 00853041003000 - 3B Medical Aer | 2019-08-21 Aer X is a portable Oxygen concentrator |
| 00853041003703 - 3B Medical, Inc.'s Cirrus 5 | 2018-07-06 Stationary 5 lpm oxygen concentrator |
| 00853041003796 - 3B Medical, Inc. | 2018-07-06 Cirrus 6" humidifier extension tube |
| 00853041003819 - 3B Medical, Inc | 2018-07-06 3B Medical, Inc. filter replacements for cabinent and panel filters |
| 00853041003048 - 3B Medical, Inc. | 2018-03-29 replacement headgear for 3B Medical's ECCO full face mask, this headgear is not size specific |
| 00853041003079 - 3B medical, inc. | 2018-03-29 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size SMALL |
| 00853041003086 - 3B Medical, Inc. | 2018-03-29 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size MEDIUM |