Pneupac
GUDID 15019517189520
ICU MEDICAL, INC.
Pulmonary resuscitator, pneumatic, reusable| Primary Device ID | 15019517189520 |
| NIH Device Record Key | f72b8a44-1a5d-477d-8dbc-bedf2b01013d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pneupac |
| Version Model Number | 520A1126NESNONEU |
| Company DUNS | 118380146 |
| Company Name | ICU MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15019517189520 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071527
FDA Product Code
| BTL | Ventilator, emergency, powered (resuscitator) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-04-23 |
| Device Publish Date | 2019-07-19 |
On-Brand Devices [Pneupac]
| 10610586045752 | WW331002S |
| 10610586045738 | 520A1300US |
| 10610586045721 | 520A1299US |
| 10610586045653 | 150003V |
| 10610586045622 | 130002V |
| 10610586045578 | 150003 |
| 10610586045561 | 130002 |
| 10610586045493 | 122005 |
| 10610586045486 | 120003 |
| 10610586045479 | 120002 |
| 10610586038259 | 130003 |
| 15019517189520 | 520A1126NESNONEU |
Trademark Results [Pneupac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PNEUPAC 75758396 2345686 Live/Registered |
SMITHS MEDICAL INTERNATIONAL LIMITED 1999-07-23 |
 PNEUPAC 73372613 1295889 Dead/Cancelled |
Pneupac Limited 1982-07-01 |
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