Stat Profile - Remanufactured Prime ES Plus w/ Tray - NOVA BIOMEDICAL CORPORATION

Duns Number:070617139

Device Description: Remanufactured Prime ES Plus w/ Tray

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More Product Details

Catalog Number

62636

Brand Name

Stat Profile

Version/Model Number

Prime ES Plus

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

CHL

Product Code Name

Electrode measurement, blood-gases (pco2, po2) and blood ph

Device Record Status

Public Device Record Key

c673fafc-4266-48aa-b258-0520c50b6510

Public Version Date

February 11, 2020

Public Version Number

1

DI Record Publish Date

February 03, 2020

Additional Identifiers

Package DI Number

10385480626368

Quantity per Package

1

Contains DI Package

00385480626361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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