Duns Number:781100966
Device Description: Box of 50 Test Cartridges (5 vials of 10) and 60 Capillary Transfer Tubes (3 bags of 20)
Catalog Number
-
Brand Name
Mission Plus Hemoglobin (Hb) Test Cartridges
Version/Model Number
C132-3041
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
K122553,K122553,K122553
Product Code
GKR
Product Code Name
SYSTEM, HEMOGLOBIN, AUTOMATED
Public Device Record Key
7b25c761-506e-41d8-8112-e641926447a5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20682607610543
Quantity per Package
80
Contains DI Package
00682607610549
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |