Purevac HVE System - HVE Mirror Tips and Hose Adapter Starter Kit - Medfruition Electronics Technology Co., Ltd

Duns Number:561149747

Device Description: HVE Mirror Tips and Hose Adapter Starter Kit

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More Product Details

Catalog Number

-

Brand Name

Purevac HVE System

Version/Model Number

HVE Mirror Tips and Hose Adapter Starter Kit

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

EAX

Product Code Name

Mirror, Mouth

Device Record Status

Public Device Record Key

921b6bae-add5-450e-b15c-deb7db308a89

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDFRUITION ELECTRONICS TECHNOLOGY CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2