Duns Number:064608573
Device Description: 100 Adaptors for an In vitro diagnostics device. For use with Siemens Healthcare Diagnosti 100 Adaptors for an In vitro diagnostics device. For use with Siemens Healthcare Diagnostics blood collection capillary tubes and analyzers.
Catalog Number
478647
Brand Name
Adapters
Version/Model Number
10330785
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)
-
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
da8f588e-4553-4b85-99e3-d6d1ebac1824
Public Version Date
January 19, 2022
Public Version Number
4
DI Record Publish Date
September 24, 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 | 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 |