MedSource Oxygen Adapter - Chemetron Adapter - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Chemetron Adapter

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More Product Details

Catalog Number

-

Brand Name

MedSource Oxygen Adapter

Version/Model Number

MS-28410

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

e491e9a7-adfd-410c-ab63-8f4af35b20d1

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Additional Identifiers

Package DI Number

00840155408821

Quantity per Package

5

Contains DI Package

00840155408814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90