Proscope™

Basic Information

• Brand Name: Proscope™
• Primary DI: 00634782070045
• Version / Model: 830-13TBK
• Catalog Number: 830-13TBK
• Company Name: AMERICAN DIAGNOSTIC CORP
• Labeler DUNS: 108999095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: aded7d79-9081-44d5-ba45-0386a9817cf6

Device Description

ADCUFF Nylon Cuff,Thigh, Black, LF

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
Package	00634782569716	GS1	Master Case	8	In Commercial Distribution
Primary	00634782070045	GS1
Unit of Use	00634782024185	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Thigh, 40-66cm

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit