| Primary Device ID | 20629160000053 |
| NIH Device Record Key | 68b3d48a-e947-4c53-9ece-c78b0b830df0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BOMImed Saver |
| Version Model Number | MAC 4 |
| Catalog Number | OL-3314 |
| Company DUNS | 248200149 |
| Company Name | BOMImed Inc |
| 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 | 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 | false |
| Phone | 204-633-2664 |
| regulatory@bomimed.com | |
| Phone | 204-633-2664 |
| regulatory@bomimed.com | |
| Phone | 204-633-2664 |
| regulatory@bomimed.com | |
| Phone | 204-633-2664 |
| regulatory@bomimed.com | |
| Phone | 204-633-2664 |
| regulatory@bomimed.com | |
| Phone | 204-633-2664 |
| regulatory@bomimed.com | |
| Phone | 204-633-2664 |
| regulatory@bomimed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10629160000056 [Primary] |
| GS1 | 20629160000053 [Package] Contains: 10629160000056 Package: Case [20 Units] In Commercial Distribution |
| CCW | Laryngoscope, Rigid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-16 |
| Device Publish Date | 2021-08-06 |
| 20629160000053 | BOMImed Disposable Saver Laryngoscope Blade |
| 20629160000039 | BOMImed Disposable Saver Laryngoscope Blade |