Duns Number:122561087
Device Description: BD™ Universal Viral Transport for Viral, Chlamydial, Mycoplasmal and Ureaplasmal Spe BD™ Universal Viral Transport for Viral, Chlamydial, Mycoplasmal and Ureaplasmal Specimens 3 mL Vial, Flock Regular
Catalog Number
220528
Brand Name
BD™ Universal Viral Transport Flock Regular
Version/Model Number
220528
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
K042970,K042970
Product Code
JSM
Product Code Name
CULTURE MEDIA, NON-PROPAGATING TRANSPORT
Public Device Record Key
fad3f226-17da-4177-b37a-5d88f06dfbcd
Public Version Date
July 06, 2018
Public Version Number
2
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 |