Duns Number:005460723
Device Description: iSWAB Microbiome Collection Tube 1.0 ml
Catalog Number
ISM-T-1200
Brand Name
Mawi DNA Technologies
Version/Model Number
ISM-T-1200
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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
6397d1c4-3635-4eb0-9128-7641b1142bd6
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 2022
Package DI Number
10850040712121
Quantity per Package
50
Contains DI Package
00850040712124
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Rack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |