Duns Number:198227881
Device Description: SunTech Tango BP Monitor Large Adult Reusable Cuff with microphone, 27- 40 cm, for use wit SunTech Tango BP Monitor Large Adult Reusable Cuff with microphone, 27- 40 cm, for use with Tango M2
Catalog Number
6901-026-03
Brand Name
Welch Allyn, Inc.
Version/Model Number
901146
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122401
Product Code
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
f6249a10-a6f5-45bd-9e31-f9f925740fea
Public Version Date
June 29, 2022
Public Version Number
3
DI Record Publish Date
September 24, 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 |