| Primary Device ID | 16948538368197 |
| NIH Device Record Key | 25f148a2-cca4-4051-9e0a-5a974dbc9e8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Siesta Nasal Mask(M) |
| Version Model Number | N5B(Medium) |
| Company DUNS | 526010310 |
| Company Name | BMC Medical 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 06948538368190 [Primary] |
| GS1 | 16948538368197 [Package] Contains: 06948538368190 Package: [22 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 | 2023-11-30 |
| Device Publish Date | 2023-11-22 |
| 06948538369173 - PAP Link | 2025-09-29 PAP Link |
| 06948538363553 - / | 2025-06-17 G3 X APAP |
| 06948538363560 - / | 2025-06-17 G3 X APAP |
| 06948538366363 - / | 2025-06-17 G3 X BPAP 25A |
| 06948538366387 - / | 2025-06-17 G3 X BPAP System |
| 36948538368030 - Siesta 2 Nasal Mask | 2024-04-10 Siesta 2 Nasal Mask |
| 36948538368047 - Siesta 2 Nasal Mask | 2024-04-10 Siesta 2 Nasal Mask |
| 36948538368054 - Siesta 2 Nasal Mask | 2024-04-10 Siesta 2 Nasal Mask |