Ohio - Collection Bottle, Plastic 350mL - OHIO MEDICAL, LLC

Duns Number:005192885

Device Description: Collection Bottle, Plastic 350mL

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More Product Details

Catalog Number

6700-0208-500

Brand Name

Ohio

Version/Model Number

B5

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Device Record Status

Public Device Record Key

a0e8350d-9bc0-4c5e-b2d7-94a4f0993bd9

Public Version Date

May 07, 2021

Public Version Number

1

DI Record Publish Date

April 29, 2021

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