Duns Number:198227881
Device Description: REFURB COMP VSM6700 SPN ST
Catalog Number
67NXTX-R
Brand Name
Welch Allyn, Inc.
Version/Model Number
901060
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132808,K132808
Product Code
MWI
Product Code Name
Monitor, physiological, patient (without arrhythmia detection or alarms)
Public Device Record Key
d3d41207-2a69-4247-bfba-46ec6a33e3d7
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
May 03, 2021
Package DI Number
00732094322637
Quantity per Package
1
Contains DI Package
00732094322620
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |