Coffee, Coffea spp. - HYCOR BIOMEDICAL LLC

Duns Number:010558476

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More Product Details

Catalog Number

74280

Brand Name

Coffee, Coffea spp.

Version/Model Number

F221

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

Yes

Prescription Use (Rx)

-

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

MVU

Product Code Name

Reagents, Specific, Analyte

Device Record Status

Public Device Record Key

d360494f-03ca-4e96-93fc-9673a834eb5f

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYCOR BIOMEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 158
2 A medical device with a moderate to high risk that requires special controls. 148