enFlow™ 980200EU
GUDID 50190752178289
Disposable IV Fluid/Blood Warmer Cartridge Model 200
VYAIRE MEDICAL, INC.
Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set Convection blood/fluid warmer set| Primary Device ID | 50190752178289 |
| NIH Device Record Key | 5f7ca0cd-91db-475c-b93c-b4670fe9085b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | enFlow™ |
| Version Model Number | 980200EU |
| Catalog Number | 980200EU |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752178281 [Primary] |
| GS1 | 20190752178288 [Package] Contains: 10190752178281 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 50190752178289 [Package] Contains: 20190752178288 Package: Case [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130867
FDA Product Code
| LGZ | Warmer, thermal, infusion fluid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-06 |
| Device Publish Date | 2021-03-29 |
On-Brand Devices [enFlow™]
| 10190752188624 | Power Cord - US, Canada, Latin America |
| 50190752178289 | Disposable IV Fluid/Blood Warmer Cartridge Model 200 |
| 50190752147100 | Disposable IV Fluid/Blood Warmer Cartridge with IV Extension Model 202 |
| 10190752125803 | Controller Model 121 |
| 10190752125780 | IV Fluid/Blood Warmer Model 100 |
Trademark Results [enFlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENFLOW 78931674 3413404 Dead/Cancelled |
VITAL SIGNS, INC. 2006-07-18 |
 ENFLOW 78922433 3407218 Live/Registered |
VITAL SIGNS, INC. 2006-07-05 |
 ENFLOW 78922373 not registered Dead/Abandoned |
Enginivity LLC 2006-07-05 |
 ENFLOW 78722539 3167989 Dead/Cancelled |
LINDE GAS LLC 2005-09-28 |
 ENFLOW 77833560 3784492 Dead/Cancelled |
Goode, William H. 2009-09-23 |
 ENFLOW 76467220 2897796 Dead/Cancelled |
LINDE AG 2002-11-14 |
 ENFLOW 76461769 2870234 Dead/Cancelled |
LINDE AG 2002-10-25 |
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