| Primary Device ID | 46923980104426 |
| NIH Device Record Key | d29b1e4e-2534-46e3-8e96-1daabe5c4274 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | AB0260 |
| Catalog Number | AT15-DS |
| Company DUNS | 527333326 |
| Company Name | GaleMed Xiamen 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06923980104428 [Primary] |
| GS1 | 46923980104426 [Package] Contains: 06923980104428 Package: Carton [20 Units] In Commercial Distribution |
| BZO | Set, Tubing And Support, Ventilator (W Harness) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-30 |
| Device Publish Date | 2024-10-22 |
| 06923980102028 | Berman Airway 9cm |
| 06923980101939 | Guedel Airway 9cm, Yellow |
| 06923980101922 | Guedel Airway 8cm, Green |
| 06923980104435 | Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm |
| 46923980108844 | Silicone J-Circuit, Adult |
| 06923980104824 | Softip-1 Nasal Cannula, Adult |
| 46923980114340 | PEEP Valve, 5-20cmH2O, 30F w/adapter |
| 46923980104426 | Theta Circuit, 150cm |