Catalog Number

-

Brand Name

Tube set for irrigation and suction, single-use

Version/Model Number

4170.225

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K935763,K990732,K935763,K990732

Product Code

DQI

Product Code Name

Withdrawal/Infusion Pump

Public Device Record Key

1152110b-7b85-42d1-bdf4-8f6206e0b4e4

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

February 06, 2017

Package DI Number

04056702002398

Quantity per Package

10

Contains DI Package

04056702002381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-