Catalog Number

M7005

Brand Name

ASEPT

Version/Model Number

M7005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

-

Product Code

DWM

Product Code Name

Apparatus, Suction, Patient Care

Public Device Record Key

14ffc4fb-70f7-4151-80c7-592c550fcac0

Public Version Date

September 06, 2019

Public Version Number

2

DI Record Publish Date

March 31, 2019

Package DI Number

20813623017058

Quantity per Package

10

Contains DI Package

10813623017051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-