AeroTech I Shield 177-095

GUDID 00879942070101

AeroTech I Shield, part of Radioaerosol Administration System

CAPINTEC, INC.

Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set Radioaerosol administration set

• Primary Device ID: 00879942070101
• NIH Device Record Key: 280d2ea5-02f6-4556-b176-dabc7a516fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroTech I Shield
• Version Model Number: 177-095
• Catalog Number: 177-095
• Company DUNS: 047684501
• Company Name: CAPINTEC, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com
• Phone: 201-805-9500
• Email: flo-techsupport@mirion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879942070101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800023

FDA Product Code

• IYT: System, Rebreathing, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-16
• Device Publish Date: 2022-08-08

Devices Manufactured by CAPINTEC, INC.

• 00879942070125 - AeroTech I Convenience Kit, Small Particle: 2022-08-17 AeroTech I Convenience Kit, Small Particle part of Radioaerosol Administration System
• 00879942070101 - AeroTech I Shield: 2022-08-16AeroTech I Shield, part of Radioaerosol Administration System
• 00879942070101 - AeroTech I Shield: 2022-08-16 AeroTech I Shield, part of Radioaerosol Administration System
• 00879942070118 - AeroTech I Convenience Kit, Standard: 2022-08-16 AeroTech I Convenience Kit, Standard part of Radioaerosol Administration System
• 00879942070132 - AeroTech I Convenience Kit, Venti Pak: 2022-08-16 AeroTech I Convenience Kit, Venti Pak, for Radioaerosol Administration System
• 00879942070149 - Venti-Scan IV Shield: 2022-08-16 Venti-Scan IV Shield, part of Radioaerosol Administration System
• 00879942070156 - Venti-Scan IV Convenience Kit, 24 inch tubing: 2022-08-16 Venti-Scan IV Convenience Kit, 24 inch tubing, part of Radioaerosol Administration System
• 00879942070163 - Venti-Scan IV Convenience Kit, Venti Pak: 2022-08-16 Venti-Scan IV Convenience Kit, Venti Pak, part of Radioaerosol Administration System
• 00879942070170 - Venti-Scan IV Convenience Kit, 12 inch tubing: 2022-08-16 Venti-Scan IV Convenience Kit, 12 inch tubing, for Radioaerosol Administration System