Vital Signs - CO2 B-Line, Disposable - Carefusion Finland 320 Oy

Duns Number:367919120

Device Description: CO2 B-Line, Disposable

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More Product Details

Catalog Number

402667-003

Brand Name

Vital Signs

Version/Model Number

402667-003

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

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 Details

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

617f2f9d-34ef-44ff-947b-e127db0c2119

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

20885403248952

Quantity per Package

50

Contains DI Package

10885403248955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CAREFUSION FINLAND 320 OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 363