Duns Number:013847849
Device Description: The LifeTec Elite system is a blood establishment computer system that receives and stores
Catalog Number
-
Brand Name
LifeTec Elite
Version/Model Number
1.0
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
BK060032
Product Code
MMH
Product Code Name
Blood Establishment Computer Software And Accessories
Public Device Record Key
ff106c82-315c-42ed-a4cb-1bbde50b2e23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |