Duns Number:138781799
Device Description: Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/KNOB
Catalog Number
-
Brand Name
Tenacore
Version/Model Number
TFCT-CM03-0201
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043075
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
35608c71-f179-4f7b-ad33-c7eebb62d0c1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |