Kendall

Basic Information

• Brand Name: Kendall
• Primary DI: 20192253017295
• Version / Model: 31177705
• Catalog Number: 31177705
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-05-06
• Public Version: 2
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 24cc6197-d3a8-42b6-8b26-a3536dcda4ea

Device Description

Kendall 1010P Defibrillation electrode ( 1PR/PK)

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
11130	Electrode conductive skin pad, single-use	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253017296	GS1	Pair	1	In Commercial Distribution
Primary	20192253017295	GS1
Unit of Use	10192253017298	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius