MR Patient Care Adult LoFLo CO2 with O2 Cannulas (100) - MR Patient Care Adult LoFLo CO2 with O2 Cannulas - WESTMED, INC.

Duns Number:092673953

Device Description: MR Patient Care Adult LoFLo CO2 with O2 Cannulas (100)

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More Product Details

Catalog Number

-

Brand Name

MR Patient Care Adult LoFLo CO2 with O2 Cannulas (100)

Version/Model Number

P185361

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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"

Yes

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

cf101715-773f-4983-8751-c2700c1f0f25

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

June 30, 2021

Additional Identifiers

Package DI Number

10709078012751

Quantity per Package

100

Contains DI Package

00709078012754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320