Duns Number:041810693
Device Description: 44 inch (122 cm) with 3 pressure activated checkvalves, inline checkvalve, detachable. Ap 44 inch (122 cm) with 3 pressure activated checkvalves, inline checkvalve, detachable. Approximate priming volume 6.4mL.
Catalog Number
-
Brand Name
Q2 Checkmate Extension Set
Version/Model Number
9543
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
K800825,K800825
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
ecf5d6bf-571c-4ffd-ad13-bf669a5915c8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 10, 2016
Package DI Number
20634624095438
Quantity per Package
50
Contains DI Package
00634624095434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |