UPMM

Basic Information

• Brand Name: UPMM
• Primary DI: 00816396020818
• Version / Model: 3078-00-15
• Catalog Number: 3078-00-15
• Company Name: IVY BIOMEDICAL SYSTEMS, INC.
• Labeler DUNS: 109132019
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 58a1f1ed-40be-4091-a724-b3eaab21868d

Device Description

Cardiac Gating Module & Accessory Kit

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40743	Nuclear medicine system synchronizer	A physiological monitoring unit used a component of a diagnostic nuclear medicine imaging system, e.g., single photon emission computed tomography (SPECT), positron emission tomography (PET) or gamma camera, that produces a signal which enables image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic nuclear medicine imaging applications. It is sometimes referred to as a gated imaging accessory or trigger.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816396020818	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091985	000

Device Sizes

Type	Value	Unit	Text
Weight	2.5	Pound
Depth	6.7	Inch
Width	12	Inch
Height	2.5	Inch