Duns Number:080028910
Device Description: Control Solution - High, 1 x 2.5 mL
Catalog Number
1491A
Brand Name
BREEZE® 2
Version/Model Number
1491A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2018
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062347,K062347,K062347,K062347
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
00347610-621a-42bd-95fb-2ebe52ac71de
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50301931491017
Quantity per Package
32
Contains DI Package
40301931491010
Package Discontinue Date
January 31, 2018
Package Status
Not in Commercial Distribution
Package Type
out.shipper/lg.case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |