| Primary Device ID | 07045432120486 |
| NIH Device Record Key | 604415d8-ea1f-4faf-8ad0-285d4265b856 |
| Commercial Distribution Discontinuation | 2026-01-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Laerdal Silicone Masks |
| Version Model Number | 851700-1 |
| Company DUNS | 730624095 |
| Company Name | Laerdal Medical AS |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07045432120486 [Primary] |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07045432120486]
High-level Disinfectant;Moist Heat or Steam Sterilization
[07045432120486]
High-level Disinfectant;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-06 |
| Device Publish Date | 2026-01-29 |
| 07045432120509 | Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator. |
| 07045432120493 | Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator. |
| 07045432120486 | Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator. |
| 07045432120479 | Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator. |
| 07045432120462 | Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator. |