Catalog Number

1035

Brand Name

SeromaCath

Version/Model Number

1035 Pouch

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

K905733,K905733

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Public Device Record Key

671eae60-8564-46d3-a712-3babc44f0065

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

May 10, 2017

Package DI Number

00854373007025

Quantity per Package

5

Contains DI Package

00854373007032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box