Defibtech ARM XR Stabilization Strap

Basic Information

• Brand Name: Defibtech ARM XR Stabilization Strap
• Primary DI: 00815098020829
• Version / Model: RSS-U2000
• Company Name: DEFIBTECH, L.L.C.
• Labeler DUNS: 128340200
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-25
• Public Version: 1
• Public Version Date: 2023-02-02
• Public Version Status: New
• Public Device Record Key: c279fdbb-1796-460b-b353-88679d3701c8

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
61908	Cardiac resuscitator, battery-powered	A battery-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)]. It may be available in a variety of forms but includes a mechanical chest compressor (e.g., plunger-type), a battery-powered control unit, and patient straps/supports. The device is typically used as an adjunct to or substitute for manual external cardiac compression in cases where manual compression is not ideal, or to prevent fatigue and improve consistency (i.e., of force, rate).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815098020829	GS1

Premarket Submissions

Submission Number	Supplement Number
K211289	000