Duns Number:828611934
Catalog Number
-
Brand Name
Medex
Version/Model Number
MX7267
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
FPK
Product Code Name
Tubing, fluid delivery
Public Device Record Key
0901fd31-a1c5-4dd0-a6dd-a69995dfbb32
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
January 19, 2017
Package DI Number
50351688505499
Quantity per Package
50
Contains DI Package
10351688505491
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 | 104 |
2 | A medical device with a moderate to high risk that requires special controls. | 36112 |