Patient Administration Set 17830

GUDID 09340598000046

CYCLOMEDICA AUSTRALIA PTY LTD

Radioaerosol administration set
Primary Device ID09340598000046
NIH Device Record Key2d1c57f6-54e9-4cd0-9d37-6992573a5736
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Administration Set
Version Model NumberNone
Catalog Number17830
Company DUNS751444290
Company NameCYCLOMEDICA AUSTRALIA PTY LTD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109340598000046 [Primary]
GS119340598000036 [Package]
Package: Carton [50 Units]
In Commercial Distribution

FDA Product Code

IYTSystem, Rebreathing, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-04-19
Device Publish Date2016-10-06

On-Brand Devices [Patient Administration Set]

09340598000046None
09340598000091None

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