ECO Range - Micro Series - GVS Technology (Suzhou) Co., Ltd.

Duns Number:420798347

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More Product Details

Catalog Number

-

Brand Name

ECO Range - Micro Series

Version/Model Number

62.002.0083.9085/751CRSA

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

Yes

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

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Device Record Status

Public Device Record Key

96a00d84-d632-4549-af17-e6def2659e14

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

35019315083024

Quantity per Package

50

Contains DI Package

15019315083020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"GVS TECHNOLOGY (SUZHOU) CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 16