| Primary Device ID | 06948538362266 |
| NIH Device Record Key | 2f129831-3314-4197-882b-4ea5ad0584ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | / |
| Version Model Number | L1(D19) |
| Company DUNS | 526010310 |
| Company Name | BMC 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06948538362266 [Primary] |
| GS1 | 16948538362263 [Package] Package: [30 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 | 2020-04-14 |
| Device Publish Date | 2020-04-06 |
| 06948538362273 | Breathing Tube (L1) |
| 06948538362266 | Breathing Tube (L1) |
| 16948538367404 | Numa II Full Face Mask Replacement Headgear |
| 16948538367398 | Numa II Full Face Mask (SML) |
| 16948538367381 | Numa II Full Face Mask (L) |
| 16948538367374 | Numa II Full Face Mask (M) |
| 16948538367367 | Numa II Full Face Mask (S) |
| 06948538362549 | Heated Tubing |
| 16948538360719 | Siesta Full Face Mask (SML) |
| 16948538367619 | Siesta Nasal Mask (XL) |
| 16948538367602 | Siesta Nasal Mask (L) |
| 16948538367596 | Siesta Nasal Mask (M) |
| 16948538367589 | Siesta Nasal Mask (S) |
| 16948538362850 | Air Filter |
| 16948538362843 | Air Filter |
| 16948538362911 | WiFi Kit |
| 16948538362751 | Filter Cap |