Duns Number:198227881
Device Description: Replacement lead set, AHA, V4-V6 with banana plugs for the WAM or AM12, white
Catalog Number
9293-046-56
Brand Name
Welch Allyn, Inc.
Version/Model Number
901006
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
MLD
Product Code Name
MONITOR, ST SEGMENT WITH ALARM
Public Device Record Key
afade40f-dffa-4850-8fb1-949f6c6e4a11
Public Version Date
June 24, 2022
Public Version Number
2
DI Record Publish Date
December 30, 2019
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 |