| Primary Device ID | 46923980110502 |
| NIH Device Record Key | 86b42d52-32ca-438e-94f5-cf60e6e4ab38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | AM0122 |
| Company DUNS | 527333326 |
| Company Name | GaleMed Xiamen Co., Ltd. |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 06923980110504 [Primary] |
| GS1 | 46923980110502 [Package] Contains: 06923980110504 Package: case [25 Units] In Commercial Distribution |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-11 |
| Device Publish Date | 2025-09-03 |
| 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 |
| 46923980104273 | Theta Circuit, 180cm |
| 46923980115811 | Disposable Oxygen Tubing R2 Star Lumen Tubing, 200cm, 6M |
| 46923980115194 | Coaxial Circuit, Adult, 1.5m |
| 46923980115187 | Anesthesia Circuit, Adult, 1.8m |
| 46923980115170 | Anesthesia Circuit, Adult, 1.2m |
| 46923980115163 | Coaxial Circuit, Adult, 1.8m |
| 46923980115156 | Anesthesia Circuit, Adult, 1.5m |
| 46923980110502 | CPAP Face Mask Set w/Hose, S |
| 46923980110496 | CPAP Face Mask Set w/Hose, M |
| 46923980104747 | CPAP Face Mask Set w/Hose, L |