Duns Number:122561087
Device Description: BD CytoRich™ Clear Collection Vial (contains: 200 - 10 mL BD CytoRich™ Clear Collection Vi BD CytoRich™ Clear Collection Vial (contains: 200 - 10 mL BD CytoRich™ Clear Collection Vials)
Catalog Number
491443
Brand Name
BD CytoRich™ Clear Collection Vial
Version/Model Number
491443
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
NNI
Product Code Name
CONTAINER, SPECIMEN, NON-STERILE
Public Device Record Key
e1edbadb-12ed-48eb-8826-f8a5066802a8
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
May 25, 2018
Package DI Number
30382904914432
Quantity per Package
8
Contains DI Package
10382904914438
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| 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 |