Duns Number:830016148
Device Description: 3M™ Littmann® Electronic Stethoscope, Black, 27", USA / Japan Only 3100BK
Catalog Number
3100BK27
Brand Name
Littmann®
Version/Model Number
3100BK27
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
K050159,K050159
Product Code
DQD
Product Code Name
STETHOSCOPE, ELECTRONIC
Public Device Record Key
029587fe-64d1-4095-9434-a60e86b2992a
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
50707387765458
Quantity per Package
3
Contains DI Package
00707387765453
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 |