Henry Schein - Compressor Nebulizer - Beijing Choice Electronic Technology Co., Ltd.

Duns Number:526882823

Device Description: Compressor Nebulizer

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More Product Details

Catalog Number

-

Brand Name

Henry Schein

Version/Model Number

112-7063

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

-

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

BTI

Product Code Name

Compressor, Air, Portable

Device Record Status

Public Device Record Key

c12ea43e-d88e-479d-9162-e020ae7cb529

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

20846841060834

Quantity per Package

8

Contains DI Package

00846841060830

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 259