Catalog Number

600-0015

Brand Name

AIR BARRIER SYSTEM STERILE NOZZLE

Version/Model Number

160-0028

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"

Yes

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

K123006,K123006,K123006

Product Code

ORC

Product Code Name

Air Filter Portable Apparatus

Public Device Record Key

c3b07fe5-0e86-493f-ae6c-8a0e27e592c5

Public Version Date

February 02, 2022

Public Version Number

7

DI Record Publish Date

February 19, 2021

Package DI Number

10842430115445

Quantity per Package

5

Contains DI Package

00842430115448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case