UPMM-X 4160-00-15

GUDID 00816396023178

Cardiac Gating Module & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer
Primary Device ID00816396023178
NIH Device Record Key05ad60f0-4282-4b0c-98f3-a79d23f5e465
Commercial Distribution StatusIn Commercial Distribution
Brand NameUPMM-X
Version Model Number4160-00-15
Catalog Number4160-00-15
Company DUNS109132019
Company NameIVY BIOMEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com

Device Dimensions

Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound
Height2.5 Inch
Width12 Inch
Depth6.7 Inch
Weight2.5 Pound

Device Identifiers

Device Issuing AgencyDevice ID
GS100816396023178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [UPMM-X]

00816396023178Cardiac Gating Module & Accessory Kit
00816396021563Cardiac Gating Module FRU
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.