Duns Number:042126640
Device Description: single use, sterile pouched polyester spun swabs for specimen ciollection sampling from na single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares
Catalog Number
-
Brand Name
XpressCollect TM Sterile Polyester Spun Swab in Tube 1 ea.
Version/Model Number
60600
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
KXG
Product Code Name
Applicator, Absorbent Tipped, Sterile
Public Device Record Key
80f58c0b-53b1-44e6-a33a-a03c4cb9af1e
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
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 | 8 |