Duns Number:195501127
Device Description: UltraCrit Hematocrit Measurement Device (UltraCrit) employs ultrasound technology to accur UltraCrit Hematocrit Measurement Device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood.
Catalog Number
270-111
Brand Name
UltraCrit Cuvettes
Version/Model Number
270-111
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
Yes
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
-
Product Code
GKF
Product Code Name
Instrument, Hematocrit, Automated
Public Device Record Key
5e3cec12-9665-4d90-bd2c-6f2eecc58b86
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
August 25, 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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 11 |