| Primary Device ID | 07045432092448 |
| NIH Device Record Key | f5701e3d-bc1d-48ed-9ce1-7fb1792f8424 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newborn Mask - Size 0 Qty 10 - Snap Design (US) |
| Version Model Number | LGH-84615601 |
| Catalog Number | LGH-84615601 |
| 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 | |
| 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 |
| 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 | 07045432092448 [Primary] |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
[07045432092448]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-05 |
| Device Publish Date | 2020-10-28 |
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| 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 |
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