Duns Number:689908411
Device Description: BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contractio BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree.
Catalog Number
MKT-350-1509
Brand Name
N/A
Version/Model Number
BT-350L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K103545,K103545,K103545
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
62cd5288-e792-4e18-a80e-59761896918f
Public Version Date
June 05, 2020
Public Version Number
5
DI Record Publish Date
June 03, 2016
Package DI Number
10887529000059
Quantity per Package
1
Contains DI Package
00887529000052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |