| Primary Device ID | 06970888443876 |
| NIH Device Record Key | a5005a18-09c2-4f02-8c5a-443192f600a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultra EX |
| Version Model Number | Size 5.0 |
| Catalog Number | 1038050 |
| Company DUNS | 561008872 |
| Company Name | Jiangxi Yiles Medical Co., Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 06970888443876 [Primary] |
| GS1 | 16970888443873 [Package] Package: [10 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 | 2023-08-18 |
| Device Publish Date | 2023-08-10 |
| 06970888443883 | Laryngeal Mask Airway Reusable Size 6.0 |
| 06970888443876 | Laryngeal Mask Airway Reusable Size 5.0 |
| 06970888443869 | Laryngeal Mask Airway Reusable Size 4.0 |
| 06970888443852 | Laryngeal Mask Airway Reusable Size 3.0 |
| 06970888443845 | Laryngeal Mask Airway Reusable Size 2.5 |
| 06970888443838 | Laryngeal Mask Airway Reusable Size 2.0 |
| 06970888443821 | Laryngeal Mask Airway Reusable Size 1.5 |
| 06970888443814 | Laryngeal Mask Airway Reusable Size 1.0 |