DISPOSABLE XENON KITFOR NUCLEAR MEDICINE 20005

GUDID 00612649101903

XENON CIRCUIT

King Systems Corporation

Xenon administration system, diagnostic nuclear medicine

• Primary Device ID: 00612649101903
• NIH Device Record Key: 3b24802f-42e7-4872-bf0b-2001498a42b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE XENON KITFOR NUCLEAR MEDICINE
• Version Model Number: 20005
• Catalog Number: 20005
• Company DUNS: 009299017
• Company Name: King Systems Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612649101903 [Package]; Contains: 00612649185279; Package: [20 Units]; In Commercial Distribution
GS1	00612649185279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953513

FDA Product Code

• IYT: System, rebreathing, radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [DISPOSABLE XENON KITFOR NUCLEAR MEDICINE]

• 00612649165769: XENON CIRCUT 20/CS
• 00612649101903: XENON CIRCUIT