Duns Number:514773159
Device Description: PC-ECG Wireless Receiver Device for Stress-Test ECG.The 1200WR is the Digital RF Receiver PC-ECG Wireless Receiver Device for Stress-Test ECG.The 1200WR is the Digital RF Receiver unit of the PC-ECG 1200W System.
Catalog Number
1200WR-D-00-01
Brand Name
Receiver for 1200W with ECG trigger (TTL) output
Version/Model Number
PCECG 1200WR
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
MWI
Product Code Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Public Device Record Key
c4caedeb-4d46-4056-9882-327cfcdb8954
Public Version Date
September 30, 2019
Public Version Number
4
DI Record Publish Date
October 26, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 213 |