Duns Number:198227881
Device Description: SERV KIT MASIMO MOD SpO2 RRA REPR 4thED
Catalog Number
107289
Brand Name
Welch Allyn, Inc.
Version/Model Number
901012
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121013
Product Code
MWI
Product Code Name
Monitor, physiological, patient (without arrhythmia detection or alarms)
Public Device Record Key
e309cc7b-84c4-4f38-9a52-b3f105b19977
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
March 19, 2020
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 |