| Primary Device ID | 07045430075559 |
| NIH Device Record Key | c98fb5f0-4384-4daf-8e33-a2757b26207c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Laerdal Paediatric PM w/Gloves in Red/Black |
| Version Model Number | 820052 |
| Catalog Number | 820052 |
| 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 | true |
| 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 |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07045430075559 [Primary] |
| GS1 | 07045432068498 [Package] Package: Carton [10 Units] In Commercial Distribution |
| CBP | Valve, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-19 |
| 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 |