Duns Number:198227881
Device Description: Welch Allyn Professional Stethoscope; Stainless Steel Double-Head Chestpiece (Adult Diaphr Welch Allyn Professional Stethoscope; Stainless Steel Double-Head Chestpiece (Adult Diaphragm and Low-Frequency Bell), Single Lumen Latex-Free Tubing; 28 in/71.1 cm; Navy
Catalog Number
5079-137
Brand Name
Welch Allyn, Inc.
Version/Model Number
901039
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)
-
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
624f9f88-2d55-4473-af89-f6aa67b862d2
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2020
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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |