| Primary Device ID | 07045432119947 |
| NIH Device Record Key | c98afff2-e2ab-4e35-9ffd-a338bedacf8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pocket Mask O2, PB (EN) |
| Version Model Number | 83000133 |
| Catalog Number | 83000133 |
| Company DUNS | 730624095 |
| Company Name | Laerdal Medical AS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com | |
| Phone | (877) 523-7325 |
| customerservice@laerdal.com |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07045432119909 [Primary] |
| GS1 | 07045432119947 [Package] Contains: 07045432119909 Package: Carton [10 Units] In Commercial Distribution |
| KGB | Mask, Oxygen, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-06 |
| Device Publish Date | 2025-07-29 |
| 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) | 2025-08-06The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source. |
| 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 |