JOHN BUNN - Neb-u-Tyke Nebulizer Compressor - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: Neb-u-Tyke Nebulizer Compressor

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More Product Details

Catalog Number

-

Brand Name

JOHN BUNN

Version/Model Number

JB0112-071

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

e9446200-38a0-4136-9116-fc290f001050

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

M368JB01120712

Quantity per Package

6

Contains DI Package

M368JB01120711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202