RPM Respiratory Gating System

GUDID 00899475002479

VARIAN MEDICAL SYSTEMS, INC.

Real-time position management respiratory gating system, optical
Primary Device ID00899475002479
NIH Device Record Key74713607-3425-4f3c-8544-c3ce5a9e1492
Commercial Distribution StatusIn Commercial Distribution
Brand NameRPM Respiratory Gating System
Version Model Number1.8
Company DUNS009120817
Company NameVARIAN 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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100899475002479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-29
Device Publish Date2022-04-21

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