PremierPro

Basic Information

• Brand Name: PremierPro
• Primary DI: 00818566010230
• Version / Model: 6310
• Catalog Number: 6310
• Company Name: PRESTIGE AMERITECH, LTD.
• Labeler DUNS: 199692794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-02
• Public Version: 3
• Public Version Date: 2026-03-23
• Public Version Status: Update
• Public Device Record Key: bbb18558-a3c0-49a6-a0ee-c50cf082734f

Device Description

Single-Head Stethoscope Black

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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 external stethoscope	A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, 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 user’s ears. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818566010237	GS1	case	25	In Commercial Distribution
Primary	00818566010230	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	30	Inch