Catalog Number

1A8504

Brand Name

NA

Version/Model Number

1A8504

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

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Public Device Record Key

126f1528-a1f9-4ff5-8b4d-c955bcd9412f

Public Version Date

October 11, 2022

Public Version Number

7

DI Record Publish Date

January 05, 2017

Package DI Number

50085412046162

Quantity per Package

6

Contains DI Package

00085412046167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE