Duns Number:830432451
Device Description: enFlow™ Disposable IV Fluid/Blood Warmer Cartridge Model 200
Catalog Number
980200EU
Brand Name
enFlow
Version/Model Number
980200EU
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LGZ
Product Code Name
Warmer, thermal, infusion fluid
Public Device Record Key
5c38b33d-28cd-45a9-b299-49c686514a83
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
20885403286152
Quantity per Package
10
Contains DI Package
10885403286155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |