ResQCPR System

Basic Information

• Brand Name: ResQCPR System
• Primary DI: M5921208250001
• Version / Model: 12-0825-000
• Company Name: ADVANCED CIRCULATORY SYSTEMS INC
• Labeler DUNS: 140320396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8f8e8ef6-26d2-4d4d-8065-768da0ce67eb

Device Description

The ResQCPR system contains two ResQPODs and one ResQPump

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIZ	Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
41882	Cardiac resuscitator, manual	A manually-operated external device (a hand-powered pump) designed to be applied to the chest of a patient suffering cardiac arrest so that a healthcare professional or layperson can administer rhythmic compression to the chest in the region of the heart to provide blood flow during cardiopulmonary resuscitation (CPR). It typically consists of central piston, a soft but firm base, (a ring) that contacts the chest, a strong spiralled spring that transfers the users applied force to the piston, and a large handle for the user's hands. The compression force can be adjusted to a pre-set load to achieve equal delivered compressions to prevent damage to the ribs/organs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M5921208220000	HIBCC		2	In Commercial Distribution
Primary	M5921208250001	HIBCC
Package	M5921208230001	HIBCC	Bx	2	In Commercial Distribution

Customer Contacts

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