Duns Number:830016148
Device Description: 3M™ Littmann® Cardiology IV™ Stethoscope, Black Finish Chestpiece, Black Tube, Blue Stem a 3M™ Littmann® Cardiology IV™ Stethoscope, Black Finish Chestpiece, Black Tube, Blue Stem and Black Headset, 6201
Catalog Number
6201
Brand Name
3M™ Littmann® Cardiology IV™
Version/Model Number
6201
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)
-
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
eb87a3e9-adcf-45b4-9b23-9895e6becd83
Public Version Date
August 24, 2021
Public Version Number
1
DI Record Publish Date
August 16, 2021
Package DI Number
50707387790474
Quantity per Package
3
Contains DI Package
00707387790479
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |