Duns Number:785335381
Device Description: Hematocrit tubes, Glass, Plain, 200/vial, 40mm, for ZIP Combo microhematocrit.
Catalog Number
CNT-ZPC7-40HE
Brand Name
LW Scientific, Inc.
Version/Model Number
CNT-ZPC7-40HE
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GHY
Product Code Name
Hematocrit, Tube, Rack, Sealer, Holder
Public Device Record Key
6d19f8f9-2597-4f67-b9fd-97be360ebff5
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2020
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 |