Duns Number:939966016
Device Description: MEDIFLO 100ML VOL/50ML HR 48/CS
Catalog Number
MDE100500
Brand Name
MediFlo
Version/Model Number
MDE100500
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
K151650,K151650
Product Code
MEB
Product Code Name
Pump, Infusion, Elastomeric
Public Device Record Key
7eec7207-819d-4278-b016-933d92604a76
Public Version Date
December 01, 2020
Public Version Number
1
DI Record Publish Date
November 23, 2020
Package DI Number
10850007185111
Quantity per Package
48
Contains DI Package
00850007185114
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 28 |