| Primary Device ID | 05707480025466 |
| NIH Device Record Key | ffa30688-7926-4fe7-9255-6089039b89b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraOnce |
| Version Model Number | 321150000U |
| Catalog Number | 321150000U |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480025466 [Package] Contains: 05707480025541 Package: [10 Units] In Commercial Distribution |
| GS1 | 05707480025541 [Primary] |
| GS1 | 05707480114528 [Package] Package: [12 Units] In Commercial Distribution |
| CAE | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-10 |
| Device Publish Date | 2023-03-02 |
| 05707480025565 | Ambu AuraOnce U Size 2.5 |
| 05707480025466 | Ambu AuraOnce U Size 1.5 |
| 05707480025527 | Ambu AuraOnce U Size 6 |
| 05707480025435 | Ambu AuraOnce U Size 5 |
| 05707480025503 | Ambu AuraOnce U Size 4 |
| 05707480025497 | Ambu AuraOnce U Size 3 |
| 05707480025473 | Ambu AuraOnce U Size 2 |
| 05707480025459 | Ambu AuraOnce U Size 1 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AURAONCE 87671674 5553528 Live/Registered |
AMBU A/S 2017-11-03 |