AeroTech I Shield 177-095

GUDID 00879942070101

AeroTech I Shield, part of Radioaerosol Administration System

CAPINTEC, INC.

Radioaerosol administration set
Primary Device ID00879942070101
NIH Device Record Key280d2ea5-02f6-4556-b176-dabc7a516fbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAeroTech I Shield
Version Model Number177-095
Catalog Number177-095
Company DUNS047684501
Company NameCAPINTEC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com
Phone201-805-9500
Emailflo-techsupport@mirion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100879942070101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYTSystem, Rebreathing, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-16
Device Publish Date2022-08-08

Devices Manufactured by CAPINTEC, INC.

00879942070125 - AeroTech I Convenience Kit, Small Particle2022-08-17 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, Standard2022-08-16 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 Shield2022-08-16 Venti-Scan IV Shield, part of Radioaerosol Administration System
00879942070156 - Venti-Scan IV Convenience Kit, 24 inch tubing2022-08-16 Venti-Scan IV Convenience Kit, 24 inch tubing, part of Radioaerosol Administration System
00879942070163 - Venti-Scan IV Convenience Kit, Venti Pak2022-08-16 Venti-Scan IV Convenience Kit, Venti Pak, part of Radioaerosol Administration System
00879942070170 - Venti-Scan IV Convenience Kit, 12 inch tubing2022-08-16 Venti-Scan IV Convenience Kit, 12 inch tubing, for Radioaerosol Administration System

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