DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE 22525

GUDID 00612649103396

XENON CIRCUIT

King Systems Corporation

Xenon administration system, diagnostic nuclear medicine Xenon administration system, diagnostic nuclear medicine Xenon administration system, diagnostic nuclear medicine

• Primary Device ID: 00612649103396
• NIH Device Record Key: 2799bf20-4f22-4189-bc43-c62f0b7f09ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE
• Version Model Number: 22525
• Catalog Number: 22525
• 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	00612649103396 [Package]; Contains: 00612649186207; Package: [20 Units]; In Commercial Distribution
GS1	00612649186207 [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

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