Duns Number:689708212
Device Description: System, ecg analysis
Catalog Number
-
Brand Name
CardioCare2000
Version/Model Number
CardioCare2000
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"
-
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
K011328,K011328
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
27b1d62a-d79d-45b7-aa4d-699851e98c77
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
Package DI Number
18809276943535
Quantity per Package
4
Contains DI Package
08809276943538
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |