Duns Number:783518983
Device Description: BaaySCI Disposable Nasal Swab . Specimen collection swab . Laboratory use
Catalog Number
-
Brand Name
BaaySCI Disposable Nasal Swab
Version/Model Number
BaayNS
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)
Yes
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
db9ccc0a-7dfb-4949-9b13-1e45a09b7b56
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
June 11, 2021
Package DI Number
10891237001963
Quantity per Package
250
Contains DI Package
00891237001966
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 24 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |
U | Unclassified | 11 |