Healthdyne BX5000 Style Foam Cabinet Filters - Healthdyne BX5000 Style Foam Cabinet Filters - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Healthdyne BX5000 Style Foam Cabinet Filters

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More Product Details

Catalog Number

OF3001

Brand Name

Healthdyne BX5000 Style Foam Cabinet Filters

Version/Model Number

OF3001

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

Yes

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

JRL

Product Code Name

Unit, Filter, Membrane

Device Record Status

Public Device Record Key

677c4ae9-9347-498e-94be-1b61ba4a4931

Public Version Date

August 15, 2018

Public Version Number

2

DI Record Publish Date

May 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNSET HEALTHCARE SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 68