Omron Sprague Rappaport Stethoscope

Basic Information

• Brand Name: Omron Sprague Rappaport Stethoscope
• Primary DI: 00073796416003
• Version / Model: 416-22-BLK
• Catalog Number: 416-22-BLK
• Company Name: Omron Healthcare, Inc.
• Labeler DUNS: 054318779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-13
• Public Version: 1
• Public Version Date: 2020-07-21
• Public Version Status: New
• Public Device Record Key: 28f07b95-bed5-4771-87fe-ff31b9f53560

Device Description

Stethoscope Black, high luster chrome plated binaural with long life rugged 22 inch double tube. 3 sets of ear tips.

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: 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
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
Primary	00073796416003	GS1

Customer Contacts

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