STANDARD HARD PADDLES

Basic Information

• Brand Name: STANDARD HARD PADDLES
• Primary DI: 00883873796139
• Version / Model: 11130
• Catalog Number: 11130-000037
• Company Name: PHYSIO-CONTROL, INC.
• Labeler DUNS: 009251992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-15
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 57e0a033-2230-4c4c-8e5a-a1dd2bd22417

Device Description

PADDLE ASSY-DETACHABLE,ROHS,ENG

Device Characteristics

• Single Use: No
• 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: 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
LDD	Dc-defibrillator, low-energy, (including paddles)	Cardiovascular	870.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41062	External defibrillation electrode, adult, reusable	An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It usually consists of a cable set that terminates with electrodes (paddles) that are hand-held by the operator to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. Typically available as a set of two electrodes with a combined cable/connector, or as a single electrode with cable/connector, in which case two will be connected to the external pulse generator (EPG). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	00721902171857	GS1
Primary	00883873796139	GS1

Customer Contacts

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