Duns Number:122561087
Device Description: BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile Swab, Sampl BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile Swab, Sample Collection Tube, Sample Collection Tube Cap
Catalog Number
446250
Brand Name
BD Affirm™ Affirm VPIII Sample Collection Sets
Version/Model Number
446250
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
K920536
Product Code
LIO
Product Code Name
Device, specimen collection
Public Device Record Key
b6c664ad-52b8-4fe0-9c5c-c06cee8d568b
Public Version Date
December 21, 2020
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 |