Duns Number:198227881
Device Description: Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device with SureBP Non-invasive Blood Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device with SureBP Non-invasive Blood Pressure, Pulse Rate, MAP; Handheld; Three-Cuff Kit: Size-10, Size-11, and Size-12 FlexiPort Reusable, 2-Tube Cuffs; Soft Storage Case; Lithium-ion (#BATT11) Battery; IEC Plug Type-A and Type-C
Catalog Number
3400-MC
Brand Name
Welch Allyn, Inc.
Version/Model Number
901055
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
K101680
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
6abc803b-9b23-4204-adbd-8bfc16962dca
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
December 05, 2017
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 |