Duns Number:785335381
Device Description: Zip-IQ Combo Centrifuge, digital, 2 rotors, 6pl angled TT (15ml) and 24pl crit (75mm) roto Zip-IQ Combo Centrifuge, digital, 2 rotors, 6pl angled TT (15ml) and 24pl crit (75mm) rotors, 90-240v
Catalog Number
-
Brand Name
Zip-IQ Combo digital centrifuge with hematocrit and test tube rotors
Version/Model Number
ZIC-CMBO-2RT3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2019
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
GKG
Product Code Name
Centrifuge, Hematocrit
Public Device Record Key
cccef03f-8fa8-4196-b14e-f9cad99f56d8
Public Version Date
September 08, 2022
Public Version Number
3
DI Record Publish Date
May 07, 2018
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 | 94 |
2 | A medical device with a moderate to high risk that requires special controls. | 28 |