Catalog Number

HCS701311

Brand Name

Medline

Version/Model Number

HCS701311

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

-

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

K042349

Product Code

JCX

Product Code Name

APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Public Device Record Key

eedec235-d642-4dd1-af53-060da7387638

Public Version Date

March 24, 2021

Public Version Number

1

DI Record Publish Date

March 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-