Duns Number:240992693
Device Description: FLUID TRANSFER SET WITH VENTED SPIKE AND TWO-WAY CHECK VALVE
Catalog Number
10-1227
Brand Name
MED-RX
Version/Model Number
10-1227
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
80829518-8c0f-47ed-94be-e54da3deabd1
Public Version Date
December 27, 2018
Public Version Number
1
DI Record Publish Date
November 26, 2018
Package DI Number
50628725000775
Quantity per Package
50
Contains DI Package
00628725000770
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |