Duns Number:830432451
Device Description: enFlow™ Insulated Warmer Strap
Catalog Number
980304VS30
Brand Name
enFlow
Version/Model Number
980304VS30
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
-
Product Code
LGZ
Product Code Name
Warmer, thermal, infusion fluid
Public Device Record Key
3769f427-6866-44df-b20e-3e4e415f7498
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
50885403296862
Quantity per Package
3
Contains DI Package
20885403296861
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 | 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 |