Proscope™

Basic Information

• Brand Name: Proscope™
• Primary DI: 00634782007171
• Version / Model: 676TQ
• Catalog Number: 676TQ
• Company Name: AMERICAN DIAGNOSTIC CORP
• Labeler DUNS: 108999095
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-10-28
• Public Version: 4
• Public Version Date: 2024-11-25
• Public Version Status: Update
• Public Device Record Key: cb513b1b-367f-4d12-9d15-40dbca4f4040
• Distribution End Date: 2019-04-11

Device Description

PROSCOPE Infant Scope,31", Turquoise

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
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	00634782507176	GS1	Master Case	36	Not in Commercial Distribution	2019-04-11
Primary	00634782007171	GS1
Unit of Use	00634782024529	GS1

Customer Contacts

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