Single-Use flexible Video Bronchoscope - Hunan Vathin Medical Instrument Co., Ltd

Duns Number:554484862

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More Product Details

Catalog Number

-

Brand Name

Single-Use flexible Video Bronchoscope

Version/Model Number

BCV1-S1

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

K191828

Product Code Details

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

7993756f-4d51-4316-846c-9e45c594401e

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26