3B Luna Style Ultrafine Filter - 3B Luna Style Ultrafine Filter (1/pack) - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: 3B Luna Style Ultrafine Filter (1/pack)

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More Product Details

Catalog Number

CF8005-1

Brand Name

3B Luna Style Ultrafine Filter

Version/Model Number

CF8005-1

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)

-

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

c5f0311b-fc28-47d0-b673-5add3d4afcd7

Public Version Date

July 05, 2018

Public Version Number

1

DI Record Publish Date

June 04, 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