Catalog Number

SU100DC

Brand Name

Portable Suction Machine

Version/Model Number

SU100DC

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"

-

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

K102626,K102626

Product Code

JCX

Product Code Name

Apparatus, Suction, Ward Use, Portable, Ac-Powered

Public Device Record Key

f53d1c04-5f6d-4ec5-9606-2eabf068db79

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Package DI Number

10848530088962

Quantity per Package

2

Contains DI Package

00848530088965

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-