Duns Number:801895244
Device Description: Display Handheld Doppler with Recharger, Audio Recorder and 3 MHz Obstetrical Probe (250AR Display Handheld Doppler with Recharger, Audio Recorder and 3 MHz Obstetrical Probe (250ARSD3)
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
MC250AR-SD3
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
-
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
K024197
Product Code
KNG
Product Code Name
Monitor, Ultrasonic, Fetal
Public Device Record Key
284bebfa-40f8-4d21-a667-7cad3a7926fb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 20, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |