FRU, Stem, O2 Outlet - FRU, Stem, O2 Outlet - ACCUTRON, INC.

Duns Number:088302096

Device Description: FRU, Stem, O2 Outlet

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More Product Details

Catalog Number

23470-FRU

Brand Name

FRU, Stem, O2 Outlet

Version/Model Number

23470-FRU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 25, 2199

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

59944bf4-399e-4700-8577-3f87f3032eff

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCUTRON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 344
2 A medical device with a moderate to high risk that requires special controls. 192