Pneupac
GUDID 15019517189513
Smiths Medical ASD, Inc.
Pulmonary resuscitator, pneumatic, reusable| Primary Device ID | 15019517189513 |
| NIH Device Record Key | 51dbd6be-1964-4897-86bc-4a295f48c65b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pneupac |
| Version Model Number | 520A1125NONEU |
| 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 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15019517189513 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051322
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 |
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