| Primary Device ID | 07045432112399 |
| NIH Device Record Key | 5f38a43e-b42e-40ea-bd22-a3875d2c2b75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newborn Mask - Size 1 Qty 1 - Snap Design (US) |
| Version Model Number | 856157-1 |
| Catalog Number | 856157-1 |
| 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 | 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 | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com | |
| Phone | (800)4311055 |
| customerservice@laerdal.com |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07045432112399 [Primary] |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
[07045432112399]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 07045432101676 - McKesson CPR Mask, Barrier Dev. 73508 | 2023-02-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant. |
| 07045432112269 - Newborn Mask - Size 0 Qty 1 - Snap Design | 2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615601, LGH-84615601 |
| 07045432112399 - Newborn Mask - Size 1 Qty 1 - Snap Design (US) | 2022-12-08Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701 |
| 07045432112399 - Newborn Mask - Size 1 Qty 1 - Snap Design (US) | 2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701 |
| 07045432101690 - McKesson CPR Mask, Barrier Dev. w/O2 73509 | 2021-12-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. |
| 07045430041257 - Laerdal Thomas Tube Holder Adult | 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert |
| 07045430041264 - Laerdal Thomas Tube Holder Pedi | 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert |
| 07045430041271 - Laerdal Thomas Tube Holder Adult (Green) | 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert |
| 07045432072310 - Laerdal Thomas Select Tube Holder, Adult | 2021-10-28 The Thomas Tube Holder secures advanced airway devices, such as Endotracheal Tubes and Supraglottic Airway devices, after insert |