CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380068034
• Version / Model: SMS11AYL
• Catalog Number: SMS11AYL
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-06
• Public Version: 1
• Public Version Date: 2019-06-14
• Public Version Status: New
• Public Device Record Key: 471b46fc-fbbc-40a1-8670-2436bd67e2bb

Device Description

STETHOSCOPE MECHANICAL ALLEGIANCE ADULT SINGLE HEAD SINGLE PATIENT USE FOR NURSE YELLOW

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
LDE	STETHOSCOPE, MANUAL	Cardiovascular	870.1875	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13755	Mechanical stethoscope	A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00888499001902	GS1	BOX	10	In Commercial Distribution
Primary	10885380068034	GS1
Package	10888499001909	GS1	CASE	10	In Commercial Distribution