Duns Number:009251992
Device Description: LIFENET Export 64-BIT RELEASE 5.3.3
Catalog Number
21340-000779
Brand Name
LIFENET Export 64-BIT
Version/Model Number
21340
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2016
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
MSX
Product Code Name
SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS
Public Device Record Key
e5b86106-98e1-4231-8fe3-eb8fa719e897
Public Version Date
April 06, 2020
Public Version Number
4
DI Record Publish Date
October 30, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 588 |