Duns Number:122561087
Device Description: BD SurePrep™ Capillary Tubes- HEPARINIZED
Catalog Number
420316
Brand Name
BD SurePrep™ Capillary Tubes- HEPARINIZED
Version/Model Number
420316
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
K884623,K884623
Product Code
GIO
Product Code Name
TUBE, COLLECTION, CAPILLARY BLOOD
Public Device Record Key
026e4a3b-b1d4-4f82-8c37-94d70edf4288
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
May 25, 2018
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |