Diagnostix™

Basic Information

• Brand Name: Diagnostix™
• Primary DI: 00634782011833
• Version / Model: 920-039
• Catalog Number: 920-039
• Company Name: AMERICAN DIAGNOSTIC CORP
• Labeler DUNS: 108999095
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2019-04-22
• Public Version Status: Update
• Public Device Record Key: cba48428-dcf0-4ed2-8949-674d1d30ced7
• Distribution End Date: 2019-04-19

Device Description

Filter/Diaphgragm/Gasket,FOR MERCURY SPHYGS

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: No
• 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
DXQ	Blood Pressure Cuff	Cardiovascular	870.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16158	Mercury manual sphygmomanometer	A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, a mercury manometer, and tubing. The mercury manometer consists of a reservoir containing mercury (Hg) and a graduated column in which the mercury rises and falls in response to pressure in the cuff. The manometer may be mounted to a wall or placed on a table and is considered the gold standard for measuring blood pressure because it remains calibrated; blood pressure measurement is taken in conjunction with a stethoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00634782011833	GS1

Customer Contacts

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

Storage Conditions

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