Neptune - SafeAir ULPA Filter - STRYKER CORPORATION

Duns Number:196548481

Device Description: SafeAir ULPA Filter

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More Product Details

Catalog Number

0703-040-000

Brand Name

Neptune

Version/Model Number

0703-040-000

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

FYD

Product Code Name

APPARATUS, EXHAUST, SURGICAL

Device Record Status

Public Device Record Key

4386f17a-0ddd-4f6d-9186-c3808a935f68

Public Version Date

July 01, 2020

Public Version Number

3

DI Record Publish Date

October 17, 2019

Additional Identifiers

Package DI Number

37613327466325

Quantity per Package

24

Contains DI Package

07613327466324

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60