Xenon Master Administration Set - Mouthpiece, Rigid w/Injection Port & Bacteria - Medi/Nuclear Corporation, Inc.

Duns Number:079628327

Device Description: Mouthpiece, Rigid w/Injection Port & Bacteria Filter, Flexible Tubing, Ventilator Circuit

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More Product Details

Catalog Number

-

Brand Name

Xenon Master Administration Set

Version/Model Number

MN1212

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"

Yes

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

-

Product Code Details

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Device Record Status

Public Device Record Key

ca07ae26-fcf4-4016-830b-589f0c0d2c34

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

00857863007536

Quantity per Package

20

Contains DI Package

00857863007451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MEDI/NUCLEAR CORPORATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 90