Duns Number:198227881
Device Description: Welch Allyn Spot LXi Vital Signs Device with Nellcor SpO2, SureTemp Plus Thermometry, Sure Welch Allyn Spot LXi Vital Signs Device with Nellcor SpO2, SureTemp Plus Thermometry, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BMI Calculation, 50-Reading Memory, Connectivity Ready; 100-240 V, 50-60 Hz AC, Lithium Ion (105632) Battery; IEC Plug Type-I
Catalog Number
45NT0-E6
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
DQA
Product Code Name
Oximeter
Public Device Record Key
baaac773-c7f9-4e9f-97fb-6b22157773ea
Public Version Date
November 02, 2020
Public Version Number
7
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 |