Avaline Medical NJ LLC - 5 Pack of Vakly 4oz Sterile Specimen Cups - Avaline Medical NJ Limited Liability Company

Duns Number:079767953

Device Description: 5 Pack of Vakly 4oz Sterile Specimen Cups Individually Bagged with Screw On Lids

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More Product Details

Catalog Number

vkssc05

Brand Name

Avaline Medical NJ LLC

Version/Model Number

vkssc05

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

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Device Record Status

Public Device Record Key

04dee0de-9e25-41d2-9035-abd1a76ce390

Public Version Date

March 17, 2022

Public Version Number

3

DI Record Publish Date

February 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVALINE MEDICAL NJ LIMITED LIABILITY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 263