| Primary Device ID | 00814940021564 |
| NIH Device Record Key | 2ebc3197-8f0c-478d-9a46-4cae3b4194e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spiracle Technology - FERNO2 - DAN |
| Version Model Number | T50520 |
| Company DUNS | 836002451 |
| Company Name | Spiracle Technology |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00814940021564 [Primary] |
| KGB | Mask, Oxygen, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
| 00814940021564 - Spiracle Technology - FERNO2 - DAN | 2023-06-19CPR Mask |
| 00814940021564 - Spiracle Technology - FERNO2 - DAN | 2023-06-19 CPR Mask |
| 00814940020185 - FERNO2 HFOC | 2019-07-12 HFOC valve, refill valve for use with Bag Valve Mask resuscitator. |
| 00814940020048 - FERNO2 | 2018-08-23 MVP Manual Aspirator |
| 00814940020505 - FERNO2 | 2018-08-23 Collection Bottle With Large Bore Catheter |
| 00814940020055 - FERNO2 | 2018-07-06 BVM, Adult, Single Patient Use |
| 00814940020062 - FERNO2 | 2018-07-06 BVM, Child, Single Patient Use |
| 00814940020079 - FERNO2 | 2018-07-06 BVM, Infant, Single Patient Use |
| 00814940020109 - FERNO2 | 2018-07-06 Wall-Mounted Blood Pressure Cuff |