Duns Number:080456871
Device Description: Disposable IV Fluid/Blood Warmer Cartridge with IV Extension Model 202
Catalog Number
980202EU
Brand Name
enFlow™
Version/Model Number
980202EU
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
-
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
K130867,K130867,K130867
Product Code
LGZ
Product Code Name
Warmer, thermal, infusion fluid
Public Device Record Key
0cff9ca8-ae36-442c-a7d1-0ad2c8a58524
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
March 29, 2021
Package DI Number
50190752147100
Quantity per Package
30
Contains DI Package
20190752147109
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |