Mawi DNA Technologies - iSWAB-Discovery Human DNA Collection Tube 400 ul - Mawi Dna Technologies, LLC

Duns Number:005460723

Device Description: iSWAB-Discovery Human DNA Collection Tube 400 ul

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More Product Details

Catalog Number

ISF-T-DSC

Brand Name

Mawi DNA Technologies

Version/Model Number

ISF-T-DSC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NNL

Product Code Name

Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Device Record Status

Public Device Record Key

e32043db-409c-44a4-a78b-f9fe3ce3b7e5

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Additional Identifiers

Package DI Number

10850040712077

Quantity per Package

50

Contains DI Package

00850040712070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Rack

"MAWI DNA TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10