Gallant™

Basic Information

• Brand Name: Gallant™
• Primary DI: 05415067031990
• Version / Model: CDVRA500Q
• Catalog Number: CDVRA500Q
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-02
• Public Version: 3
• Public Version Date: 2022-02-23
• Public Version Status: Update
• Public Device Record Key: 301aeab4-5eb2-41d3-a2b8-3d89ef5c4de6

Device Description

Implantable Cardioverter Defibrillator

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWS	Implantable cardioverter defibrillator (non-CRT)	Unknown		3
OSR	Pacemaker/icd/crt non-implanted components	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35852	Single-chamber implantable defibrillator	An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067031990	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 22 – 22 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Type: Storage Environment Temperature
• Temperature Range: 72 – 72 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius