Duns Number:788289952
Catalog Number
-
Brand Name
S/W SUB VF10.0 INFINITY EXPLORER
Version/Model Number
MS33105
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141756
Product Code
MSX
Product Code Name
System,Network And Communication,Physiological Monitors
Public Device Record Key
18839a7a-8273-46aa-93dd-e1996d0aa733
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
July 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 21 |
2 | A medical device with a moderate to high risk that requires special controls. | 232 |