Easy Pulse II Oxygen Conserver - 1900 SERIES,REG,02,EP5,870,GAUGE,OG - Precision Medical, Inc.

Duns Number:112569116

Device Description: 1900 SERIES,REG,02,EP5,870,GAUGE,OG

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More Product Details

Catalog Number

-

Brand Name

Easy Pulse II Oxygen Conserver

Version/Model Number

198705OG

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

CAW

Product Code Name

Generator, Oxygen, Portable

Device Record Status

Public Device Record Key

3353c0db-7662-462c-86ba-9a450a62e7dd

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRECISION MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 106