NA

Basic Information

• Brand Name: NA
• Primary DI: 00883873863503
• Version / Model: 11131
• Catalog Number: 11131-000044
• Company Name: PHYSIO-CONTROL, INC.
• Labeler DUNS: 009251992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-06
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 4c0bed69-500d-4f4b-a9ab-c01bf7ac43d5

Device Description

Sterilizable Internal Defibrillation Paddles, LP15

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: MR Unsafe
• 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: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

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
33946	Internal defibrillation electrode, paediatric	An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a pre-pubescent patient in order to intentionally stop/start the heartbeat during cardiopulmonary surgery. It usually consists of a cable set with small-diameter, spoon-like electrodes (commonly known as internal defibrillator paddles or spoons) that are held by the operator directly to either side of the heart muscle so that the discharge passes directly through the heart. It is typically available as a set of two electrodes with insulated handles with a combined cable/connector. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883873863503	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182503	000

Device Sizes

Type	Value	Unit	Text
Length	5.6	Inch
Device Size Text, specify			Diameter: 1.0 Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 32 – 113 Degrees Fahrenheit