Primary Device ID | 15019517180381 |
NIH Device Record Key | 0de44427-c764-453e-a19e-55d6e91e50dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pneupac |
Version Model Number | 530A1167NFRNONEU |
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 |
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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15019517180381 [Primary] |
BTL | Ventilator, emergency, powered (resuscitator) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-07 |
Device Publish Date | 2019-05-30 |
15019517181173 | 510A1960NONEU |
15019517180367 | 530A1166NONEU |
15019517189513 | 520A1125NONEU |
15019517180381 | 530A1167NFRNONEU |
15019517180374 | 530A1166NFRNONEU |
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 |