NOVA - NOVA 12 TUBING HARNESS WITHOUT DILUTOR - NOVA BIOMEDICAL CORPORATION

Duns Number:070617139

Device Description: NOVA 12 TUBING HARNESS WITHOUT DILUTOR

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More Product Details

Catalog Number

13192

Brand Name

NOVA

Version/Model Number

12

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

K924743

Product Code Details

Product Code

CDS

Product Code Name

ELECTRODE, ION SPECIFIC, UREA NITROGEN

Device Record Status

Public Device Record Key

e167fb9b-f535-4cae-8f68-f29f2b1fc826

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVA BIOMEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 165
2 A medical device with a moderate to high risk that requires special controls. 210