Catalog Number

-

Brand Name

V8 WASTE DRAWER PACK

Version/Model Number

1820

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111369

Product Code

CFF

Product Code Name

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Public Device Record Key

70ae38b3-5782-4cf4-8ba1-85b59d846c0d

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

June 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-