Duns Number:064608573
Device Description: Luer Capillary (pack of 2) an in vitro diagnostics device for use on the RAPIDLab® 1200 se Luer Capillary (pack of 2) an in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzers.
Catalog Number
106050
Brand Name
Luer Capillary
Version/Model Number
10323407
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
-
Product Code
GIO
Product Code Name
TUBE, COLLECTION, CAPILLARY BLOOD
Public Device Record Key
d0cde78d-ba78-4616-8362-7e1081febd89
Public Version Date
January 19, 2022
Public Version Number
2
DI Record Publish Date
July 09, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |