Duns Number:527221254
Catalog Number
-
Brand Name
Antmed
Version/Model Number
PT153208
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
K091408,K091408
Product Code
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
66ce6efc-86e3-4b28-9ffa-6fbf6f66ec2f
Public Version Date
October 31, 2018
Public Version Number
5
DI Record Publish Date
August 25, 2017
Package DI Number
06945764415162
Quantity per Package
10
Contains DI Package
06945764415155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 112 |