Duns Number:198227881
Device Description: Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, Surveyor S19 GEN2 Patient Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2, CO2, starter kit, resistive color touchscreen 18.5 in. display with 1366 x 768 resolution, AC or lithium ion rechargeable battery operation; International power cord; AM12 Wired Acquisition Module with AHA 12-lead lead set with snap ends and 1 IEC 3 wire ECG patient cable with clip ends; Becton-Dickson invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; No printer; LAN; No mounting
Catalog Number
SUR19-SDF-CXXAX
Brand Name
Welch Allyn, Inc.
Version/Model Number
901138
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
-
Product Code
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
e84fc35f-a77d-4244-80fa-19efdaab7916
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
March 18, 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 |