Catalog Number

-

Brand Name

SUCTION LINE SPLITTER

Version/Model Number

3022000

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

Yes

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

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

2f41ca87-be38-4443-aafc-e5f5b3553310

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Package DI Number

05030267124237

Quantity per Package

100

Contains DI Package

05030267112876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-