Nasal Jet Tube - Well Lead Medical Co.,Ltd

Duns Number:544811862

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More Product Details

Catalog Number

-

Brand Name

Nasal Jet Tube

Version/Model Number

A06A065010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K211543,K211543,K211543

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

fba7c779-3409-46a8-8d8c-4e3aede3b516

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Additional Identifiers

Package DI Number

16944932776224

Quantity per Package

10

Contains DI Package

06944932776227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"WELL LEAD MEDICAL 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. 1