Catalog Number

SBD-030

Brand Name

AIRVIEW BOWIE-DICK TEST PACK

Version/Model Number

SBD-030

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

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

9872fdb6-f24c-4002-954d-92ecbd86d25c

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

November 15, 2016

Package DI Number

50732224710551

Quantity per Package

30

Contains DI Package

10732224710553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box