Catalog Number

-

Brand Name

Insufflation Filter

Version/Model Number

2000/18BEKAAUA058/0001

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

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

b4e4a1b4-601f-40b0-a7fd-f0b6a6d4ae11

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

25060120952459

Quantity per Package

50

Contains DI Package

15060120952452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner box