Duns Number:360624720
Device Description: 36 IN EXTENSION SET W/4 WAY STOPCOCK
Catalog Number
M4058
Brand Name
MaxGuard
Version/Model Number
M4058
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"
-
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
b09f5f00-4e34-4705-9673-0bd2091f8ecb
Public Version Date
January 12, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
50885403235786
Quantity per Package
50
Contains DI Package
10885403235788
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. | 43 |