Pneupac
GUDID 15019517178845
Smiths Medical International Ltd
Transport electric ventilator| Primary Device ID | 15019517178845 |
| NIH Device Record Key | 720a39ac-3119-4ef7-93bb-a98f5dc96c90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pneupac |
| Version Model Number | 530A1167NONEU |
| Company DUNS | 215590304 |
| Company Name | Smiths Medical International Ltd |
| 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 Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| 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 |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 465 KiloPascal and 1100 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 465 KiloPascal and 1700 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15019517178845 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-01-18 |
| Device Publish Date | 2019-08-01 |
On-Brand Devices [Pneupac]
| 35019315107478 | 530A1167 |
| 35019315107270 | P300NUS |
| 35019315107263 | P310NUS |
| 35019315074862 | VR1AIRNUS |
| 35019315074183 | V200DNUS |
| 35019315072738 | P200DNUS |
| 35019315071892 | B100NUS |
| 35019315071533 | APH |
| 35019517160219 | 100/905/340-CH |
| 35019517159602 | 100/905/301-CH |
| 35019517159121 | 100/905/300-CH |
| 45019315079215 | 100/905/361 |
| 45019315079208 | 100/905/360 |
| 35019315076118 | 100/905/341 |
| 35019315076101 | 100/905/340 |
| 35019517160226 | 100/905/341-CH |
| 10610586046063 | 122003 |
| 10610586046056 | 122002 |
| 35019517159664 | 100/905/320-CH |
| 35019517159640 | 100/905/302-CH |
| 15019517178845 | 530A1167NONEU |
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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