Ohio - 20' HOSE ASMBLY DH*DH OXY USA COND 1/4" MRI - OHIO MEDICAL, LLC

Duns Number:005192885

Device Description: 20' HOSE ASMBLY DH*DH OXY USA COND 1/4" MRI

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More Product Details

Catalog Number

HS-20UO-DHDHC4M

Brand Name

Ohio

Version/Model Number

HS-20UO-DHDHC4M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

453a0ed7-00ef-4f1a-8bcd-a717c64480ea

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OHIO MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6453
2 A medical device with a moderate to high risk that requires special controls. 208