Duns Number:198227881
Device Description: Welch Allyn Connex Integrated Wall System with Nellcor SpO2, SureTemp Plus Thermometry, BP Welch Allyn Connex Integrated Wall System with Nellcor SpO2, SureTemp Plus Thermometry, BP Cuff and Cord Management System, SureBP N on-invasive Blood Pressure, Pulse Rate, MAP, Programmable Alarms, BP Averaging, Adult/Pediatric/Neonate Patient Support, Four USB Ports for Accessories, Internal 802.11 a/b/g Wireless Radio; 100-240 V, 50-60 Hz AC, IE
Catalog Number
85NTVXX-B
Brand Name
Welch Allyn, Inc.
Version/Model Number
901028
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
K112687
Product Code
MWI
Product Code Name
MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
d0a61d4b-a87c-485c-b180-671ed74f347a
Public Version Date
November 10, 2021
Public Version Number
6
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 |