Duns Number:078875059
Device Description: PCA-C100BL Patient Cable is intended to be used with QT ECG device. The Patient Cable is u PCA-C100BL Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to connect electrodes placed at appropriate sites on the patient to an ECG device for general diagnostic evaluation by healthcare professionals.
Catalog Number
-
Brand Name
QT ECG
Version/Model Number
PCA-C100BL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K200722
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
eb7ab71e-8dfa-4fa7-af74-4ce7c48e4f0d
Public Version Date
August 04, 2022
Public Version Number
1
DI Record Publish Date
July 27, 2022
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. | 18 |