Catalog Number

OS-IT-LPF

Brand Name

Insufflation Filter & Tubing Set w/Push Fit Connector

Version/Model Number

OS-IT-LPF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2019

Issuing Agency

In HIBCC

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

b9e9cf16-10d1-47ac-9569-6ade06e22f59

Public Version Date

November 15, 2019

Public Version Number

3

DI Record Publish Date

November 15, 2016

Package DI Number

B354OSITLPF10

Quantity per Package

10

Contains DI Package

B354OSITLPF0

Package Discontinue Date

November 15, 2019

Package Status

Not in Commercial Distribution

Package Type

-