| 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 |
| 07045432119251 - Pocket Mask O2, PB (DE FR ES IT EN) | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119268 - Pocket Mask O2, SP Blue (DE FR ES IT EN) | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119275 - Pocket Mask O2,HC Yellow (DE FR ES IT EN) | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119299 - Pocket Mask O2, HC White Private Label | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119312 - Pocket Mask O2, SP Black Private Label | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119336 - Pocket Mask O2, SP Camo Private Label | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119879 - Pocket Mask O2,HC Yellow (EN) | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |
| 07045432119947 - Pocket Mask O2, PB (EN) | 2025-08-06 The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the re |