NA - Gas exhaust line, white conical and Colder, - GE Healthcare Finland Oy

Duns Number:401966697

Device Description: Gas exhaust line, white conical and Colder, disposable, 0.18 m/7 in

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

5514183 Gas exhaust line, white conical

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

CAI

Product Code Name

Circuit, breathing (w connector, adaptor, y piece)

Device Record Status

Public Device Record Key

b8b0f392-8a93-46c8-86b3-204b5d043c81

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

February 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE HEALTHCARE FINLAND OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 224