Duns Number:421374768
Device Description: BOKANG STETHOSCOPE is a manual stethoscope is a mechanical device used to project the soun BOKANG STETHOSCOPE is a manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
Catalog Number
-
Brand Name
BOKANG STETHOSCOPE
Version/Model Number
BK3003
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LDE
Product Code Name
Stethoscope, Manual
Public Device Record Key
0741747a-7af2-47c0-b1df-ecdafbe6435a
Public Version Date
December 26, 2018
Public Version Number
1
DI Record Publish Date
November 25, 2018
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |