Duns Number:198227881
Device Description: Surveyor Central Additional Control - configured CPU English language and CD manual; 110V Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 8 monitoring slots (single display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
Catalog Number
SCAC-AAA-BXCXX
Brand Name
Welch Allyn, Inc.
Version/Model Number
901137
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
-
Product Code
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
d30987a1-9208-4228-8676-d18478d5e412
Public Version Date
June 27, 2022
Public Version Number
3
DI Record Publish Date
May 22, 2019
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 |