Defibtech ACC Frame Configuration

Basic Information

• Brand Name: Defibtech ACC Frame Configuration
• Primary DI: 10815098020550
• Version / Model: RMF-U1000
• Company Name: DEFIBTECH, L.L.C.
• Labeler DUNS: 128340200
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b4ea0e97-ddb0-4b65-b221-57628a3e33cb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: 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
DRM	Compressor, Cardiac, External	Cardiovascular	870.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44780	Cardiac resuscitator, line-powered	A mains electricity (AC-powered), external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. The device may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815098020550	GS1

Premarket Submissions

Submission Number	Supplement Number
K141809	000