Catalog Number

B19600

Brand Name

Prevantics® Device Swab

Version/Model Number

B19600

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

K132380,K132380

Product Code

LKB

Product Code Name

Pad, Alcohol, Device Disinfectant

Public Device Record Key

50d1a2cf-7f99-4e0f-beac-beb21966d74f

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Package DI Number

10310819001523

Quantity per Package

100

Contains DI Package

00310819001526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box