Duns Number:006261481
Device Description: ACTV 9538 REVEAL US EN 3ED
Catalog Number
-
Brand Name
REVEAL® PATIENT ASSISTANT
Version/Model Number
9538
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 10, 2018
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
K103764
Product Code
DSI
Product Code Name
DETECTOR AND ALARM, ARRHYTHMIA
Public Device Record Key
7d6b00cb-d71f-47ed-9d7c-d29b8378eb97
Public Version Date
January 09, 2020
Public Version Number
6
DI Record Publish Date
June 10, 2015
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 |