Kendall

Basic Information

• Brand Name: Kendall
• Primary DI: 10884521175358
• Version / Model: 10573237
• Catalog Number: 10573237
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-06-22
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: e2e8453d-823e-4fe0-a1db-1a35d410c536

Device Description

ECG Paper

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
DSF	RECORDER, PAPER CHART	Cardiovascular	870.2810	1

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
Package	20884521175355	GS1	CASE	50	In Commercial Distribution
Primary	10884521175358	GS1
Unit of Use	30884521175352	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	100	Feet
Width	1.9375	Inch

Storage Conditions

• Type: Special Storage Condition, Specify