Duns Number:198227881
Device Description: Spot Vital Signs LXi with SureBP and Braun ThermoScan PRO 4000 Ear Thermometer (FACTORY RE Spot Vital Signs LXi with SureBP and Braun ThermoScan PRO 4000 Ear Thermometer (FACTORY REFURBISHED)
Catalog Number
450E0-E1R
Brand Name
Welch Allyn, Inc.
Version/Model Number
901056
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
DXN
Product Code Name
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Public Device Record Key
25025e27-b893-46f0-bfd1-24a5ae2dc09d
Public Version Date
November 02, 2020
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 |