Catalog Number

-

Brand Name

Axiom® CWV

Version/Model Number

3611

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

K790654,K790654,K790654

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Public Device Record Key

2a76b320-cddb-4b58-af1e-94d00e7740eb

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Package DI Number

M66536113

Quantity per Package

6

Contains DI Package

M66536111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case