| Primary Device ID | 05707480100248 |
| NIH Device Record Key | dd5db227-c5b0-45c7-88d7-ff58ca992325 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aura-i |
| Version Model Number | 329300000U |
| Catalog Number | 329300000U |
| 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 |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com |
| 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 | 05707480044221 [Primary] |
| GS1 | 05707480100248 [Package] Contains: 05707480044221 Package: [10 Units] In Commercial Distribution |
| GS1 | 05707480114443 [Package] Package: [8 Units] In Commercial Distribution |
| CAE | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2022-12-08 |
| 05707480100200 | Ambu Aura-i U Size 2.5, Disposable Laryngeal Mask |
| 05707480100125 | Ambu Aura-i U Size 1.5, Disposable Laryngeal Mask |
| 05707480100378 | Ambu Aura-i U Size 6, Disposable Laryngeal Mask |
| 05707480100323 | Ambu Aura-i U Size 5, Disposable Laryngeal Mask |
| 05707480100286 | Ambu Aura-i U Size 4, Disposable Laryngeal Mask |
| 05707480100248 | Ambu Aura-i U Size 3, Disposable Laryngeal Mask |
| 05707480100163 | Ambu Aura-i U Size 2, Disposable Laryngeal Mask |
| 05707480100088 | Ambu Aura-i U Size 1, Disposable Laryngeal Mask |