Catalog Number

0215114000

Brand Name

NA

Version/Model Number

0215114000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Public Device Record Key

89a1f0c3-6513-47ab-9750-31eeed229e8f

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

34546540865114

Quantity per Package

10

Contains DI Package

04546540865113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack