Flowmeter - 0-15 LPM Flowmeter with Ohmeda Quick Connect - MAXTEC, LLC

Duns Number:169911828

Device Description: 0-15 LPM Flowmeter with Ohmeda Quick Connect

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More Product Details

Catalog Number

R302P01

Brand Name

Flowmeter

Version/Model Number

0-15 LPM

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)

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

CAX

Product Code Name

Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Device Record Status

Public Device Record Key

c8dea7c3-066b-4cd7-967e-678dad25ebab

Public Version Date

June 30, 2022

Public Version Number

2

DI Record Publish Date

October 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXTEC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 235