NOVO Health Services, LLC - EMESIS BASIN 3 - NOVO HEALTH SERVICES, LLC

Duns Number:069936106

Device Description: EMESIS BASIN 3

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More Product Details

Catalog Number

124041

Brand Name

NOVO Health Services, LLC

Version/Model Number

124041

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2018

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

FNY

Product Code Name

Basin, Emesis

Device Record Status

Public Device Record Key

ee50be20-7478-4be5-95f5-f18446c078f7

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVO HEALTH SERVICES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 226
2 A medical device with a moderate to high risk that requires special controls. 859