Duns Number:830016148
Device Description: 3M™ Littmann® CORE Digital Stethoscope, 8483, Black, EK
Catalog Number
8483
Brand Name
3M™ Littmann®
Version/Model Number
8483
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
DQD
Product Code Name
Stethoscope, Electronic
Public Device Record Key
2c63c89c-edf1-4c13-9959-71c71031354e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 08, 2020
Package DI Number
50707387792423
Quantity per Package
3
Contains DI Package
00707387792428
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |