Insta/Vent

GUDID 00857863007284

Insta/Vent Radioaerosol Unit w/Hepa Filter & Rigid Mouthpiece

Medi/Nuclear Corporation, Inc.

Radioaerosol administration set

• Primary Device ID: 00857863007284
• NIH Device Record Key: e8c9f409-315c-435d-9d24-8a7bba1fb7fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insta/Vent
• Version Model Number: IV-600S
• Company DUNS: 079628327
• Company Name: Medi/Nuclear Corporation, Inc.
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007116 [Primary]
GS1	00857863007284 [Package]; Contains: 00857863007116; Package: Carton [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960397

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: 2018-07-06
• Device Publish Date: 2017-06-09

On-Brand Devices [Insta/Vent]

• 00857863007925: Replacement Elbow, 22mm OD x 22mm ID and Adapter Seal, .596" O.D.
• 00857863007383: Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of wood and
• 00857863007352: Insta/Vent Portable Shield, Aluminum Case
• 00857863007321: Insta/Vent Ventilator Kit w/HEPA Filter - For ventilator dependent patients
• 00857863007291: Insta/Vent Radioaerosol Unit w/HEPA Filter & Mask
• 00857863007284: Insta/Vent Radioaerosol Unit w/Hepa Filter & Rigid Mouthpiece
• 00857863007277: Insta/Vent Radioaerosol Unit w/HEPA Filter