LIFE®Regulator - All brass EMS oxygen regulator providing - LIFE CORPORATION

Duns Number:151860053

Device Description: All brass EMS oxygen regulator providing variable-flow with 12 click-stop flow-rate settin All brass EMS oxygen regulator providing variable-flow with 12 click-stop flow-rate settings from 0-25 LPM.

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More Product Details

Catalog Number

-

Brand Name

LIFE®Regulator

Version/Model Number

LIFE-EMS-025-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

4099f4eb-6a10-43a4-851e-9c640894b26e

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

June 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 3