Xenon Master Administration Set

GUDID 00857863007536

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

Medi/Nuclear Corporation, Inc.

Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use

• Primary Device ID: 00857863007536
• NIH Device Record Key: ca07ae26-fcf4-4016-830b-589f0c0d2c34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenon Master Administration Set
• Version Model Number: MN1212
• Company DUNS: 079628327
• Company Name: Medi/Nuclear Corporation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007451 [Primary]
GS1	00857863007536 [Package]; Contains: 00857863007451; Package: Carton [20 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2019-08-21
• Device Publish Date: 2017-06-09

On-Brand Devices [Xenon Master Administration Set]

• 00857863007932: Xenon Back-Up System, Complete Aero/Vent Jr. Radioaerosol Delivery System with 1 lead shield, 4
• 00857863007536: Mouthpiece, Rigid w/Injection Port & Bacteria Filter, Flexible Tubing, Ventilator Circuit
• 00857863007529: Xenon Administration Set: Face Mask, Air-Cushioned, Adult Size 5 & Bacteria Filter, Adapter, Fl
• 00857863007512: Face Mask, Air-Cushioned, Adult Size 5, w/Injection Port & Bacteria Filter, Flexible Tubing
• 00857863007505: Face Mask, Air-Cushioned, Adult size 5, w/Injection Port & Bacteria Filter
• 00857863007499: Face Mask, Air-Cushioned, Adult Size 5, & Bacteria Filter
• 00850022357565: Xenon Administration Set: Tube, HEPA Filter and face mask with adapter
• 00850022357688: Air Cushion Face Mask with direct dose luer lock.
• 00850022357671: Air Cushion Face Mask with Injection Port.
• 00850022357640: Xenon Administration Set: Air Cushion Face Mask, Direct Dose Administration Adapter with Inject
• 00850022357626: Xenon Administration Set: Air Cushion Face Mask with Direct Dose Luer Lock, Ultra-Flex tubing (e
• 00850022357619: Xenon Administration Set: Air Cushion Face Mask with Injection Port, Ultra-Flex tubing (extends
• 00850022357596: Xenon Administration Set: Air Cushion Face Mask, Direct Dose Administration Adapter with Injecti
• 00850022357558: Xenon Administration Set: Face Mask, injection port and 2 HEPA Filters
• 00850022357541: Xenon Administration Set: Face Mask, Air-Filled with injection port
• 00850022357770: Xenon Administration Set: Tube, Injection Port, HEPA Filter and Face Mask