Catalog Number

-

Brand Name

Antistatic Compact Space Chamber with Large Mask

Version/Model Number

SP-ANTI-SLUS

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143615,K143615

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

90a364e7-81c7-409a-8cb1-26d66be790af

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 13, 2017

Package DI Number

10842135100036

Quantity per Package

50

Contains DI Package

00842135100039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton