Duns Number:689908411
Device Description: BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fe BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker.
Catalog Number
MKT-200-1501
Brand Name
Hi-bebe
Version/Model Number
BT-200S
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
K052190,K052190,K052190,K052190,K052190
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
5baff0bf-12b6-41d6-8332-a67f8732dade
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 03, 2016
Package DI Number
30887529000022
Quantity per Package
20
Contains DI Package
10887529000028
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 |