Pneupac
GUDID 15019517180374
Smiths Medical ASD, Inc.
Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator| Primary Device ID | 15019517180374 |
| NIH Device Record Key | 2fdaeee1-374f-473c-9848-fb96cc6fe53b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pneupac |
| Version Model Number | 530A1166NFRNONEU |
| Company DUNS | 082005361 |
| Company Name | Smiths Medical ASD, 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 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15019517180374 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123957
FDA Product Code
| BTL | Ventilator, emergency, powered (resuscitator) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2019-05-30 |
On-Brand Devices [Pneupac]
| 15019517181173 | 510A1960NONEU |
| 15019517180367 | 530A1166NONEU |
| 15019517189513 | 520A1125NONEU |
| 15019517180381 | 530A1167NFRNONEU |
| 15019517180374 | 530A1166NFRNONEU |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.