Xenon Master Administration Set - Xenon Back-Up System, Complete Aero/Vent Jr. - Medi/Nuclear Corporation, Inc.

Duns Number:079628327

Device Description: Xenon Back-Up System, Complete Aero/Vent Jr. Radioaerosol Delivery System with 1 lead shie Xenon Back-Up System, Complete Aero/Vent Jr. Radioaerosol Delivery System with 1 lead shield, 4 radioaerosol kits, 1 rigid mouthpiece, 2 air cushioned mask and 2 safe-t-shield mouthpieces

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Xenon Master Administration Set

Version/Model Number

AV-100-XBU

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

K810819

Product Code Details

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Device Record Status

Public Device Record Key

0b870044-69b5-422b-9311-90ca004b46ea

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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