Patient Administration Set

Basic Information

• Brand Name: Patient Administration Set
• Primary DI: 09340598000091
• Version / Model: None
• Catalog Number: 17836
• Company Name: CYCLOMEDICA AUSTRALIA PTY LTD
• Labeler DUNS: 751444290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-06
• Public Version: 8
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 2d1c57f6-54e9-4cd0-9d37-6992573a5736

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYT	System, Rebreathing, Radionuclide	Radiology	892.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16784	Radioaerosol administration set	A collection of devices used to quickly deliver radioaerosol to a patient for ventilatory pulmonary scintigraphy. It is used with an aerosol pump/nebulizer or a compressed air line to generate the radioactive aerosol, and a lead (Pb) protective container to hold the radioactive solution during the inhalation procedure. It typically consists of one or several one-way valves to direct the flow of aerosol to the patient, transport tubing to carry the aerosol to the patient, a mouthpiece, and a bacteria filter to trap any exhaled aerosol. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09340598000091	GS1
Package	19340598000036	GS1	Carton	50	In Commercial Distribution