Venti-Scan 177-092

GUDID 00718175001929

Venti-Scan 24" Tubing

BIODEX MEDICAL SYSTEMS, INC.

Radioaerosol administration set
Primary Device ID00718175001929
NIH Device Record Key2554a067-ed1c-4aee-8ed8-207f12d320d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenti-Scan
Version Model Number177-092
Catalog Number177-092
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100718175001929 [Primary]
GS110718175001933 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS120718175001947 [Package]
Package: BOX [25 Units]
In Commercial Distribution
GS130718175001951 [Package]
Package: Box [50 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-24
Device Publish Date2016-11-02

On-Brand Devices [Venti-Scan]

00718175001929Venti-Scan 24" Tubing
00718175001912Venti-Scan disposable, 12" tubing

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