NA

Basic Information

• Brand Name: NA
• Primary DI: 10841983103947
• Version / Model: A/PA-9000Z
• Catalog Number: A/PA-9000Z
• Company Name: NIHON KOHDEN AMERICA, INC.
• Labeler DUNS: 021063219
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 09b72a01-0753-41ad-b39b-87f652af24f5

Device Description

PAPER, ECG1250, 9020, 10 PADS

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: No
• 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
DPS	ELECTROCARDIOGRAPH	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16754	Electrocardiographic recording paper	A device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841983103947	GS1
Unit of Use	00841983103940	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072217	000