Duns Number:006261481
Device Description: SW POS12D18 OPTIMA 1.8 GLOBAL
Catalog Number
-
Brand Name
PACEART OPTIMA™ SYSTEM
Version/Model Number
POS12D18
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
K110693
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
b309458f-d2ea-4a8c-a95b-5364c03ea12a
Public Version Date
August 02, 2018
Public Version Number
1
DI Record Publish Date
July 02, 2018
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |