| Primary Device ID | 06948538362075 |
| NIH Device Record Key | 78d61706-40cc-4d14-a893-b02a576e06db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iCodeConnect® |
| Version Model Number | 420002 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +1-863-226-6285 |
| cpewitt@3Bproducts.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06948538362075 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-10 |
| Device Publish Date | 2017-06-16 |
| 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 |
| 36948538368061 - Siesta 2 Nasal Mask | 2024-04-10 Siesta 2 Nasal Mask |
| 36948538368078 - Siesta 2 Nasal Mask | 2024-04-10 Siesta 2 Nasal Mask |
| 36948538368085 - Siesta 2 Full Face Mask | 2024-04-10 Siesta 2 Full Face Mask |
| 36948538368092 - Siesta 2 Full Face Mask | 2024-04-10 Siesta 2 Full Face Mask |
| 06948538368107 - Siesta 2 Full Face Mask | 2024-04-10 Siesta 2 Full Face Mask |