Duns Number:790605856
Catalog Number
989803152081
Brand Name
NA
Version/Model Number
989803152081
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSI
Product Code Name
DETECTOR AND ALARM, ARRHYTHMIA
Public Device Record Key
b41246c4-1006-4ed8-bfe8-2cf844b8594c
Public Version Date
November 24, 2021
Public Version Number
4
DI Record Publish Date
May 04, 2017
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 323 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 1 |