Duns Number:463625602
Device Description: DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or tes DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37ºC for inmmunohematology applications.
Catalog Number
213734
Brand Name
DG Therm
Version/Model Number
213734
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
BK120046
Product Code
PBC
Product Code Name
Manual Blood Grouping And Antibody Test Systems
Public Device Record Key
23b51e9f-41a3-4307-8b3a-9183d60a6be5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 06, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |