Advantage™

Basic Information

• Brand Name: Advantage™
• Primary DI: 00634782053383
• Version / Model: 850-6013SA
• Catalog Number: 850-6013SA
• 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: 5
• Public Version Date: 2019-07-22
• Public Version Status: Update
• Public Device Record Key: 5291e916-fcad-4ad5-b7b6-d9db7be9c37f
• Distribution End Date: 2019-04-15

Device Description

Cuff & Bladder-Digital,Small Adult, Navy

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
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	870.2100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34978	Blood pressure cuff, reusable	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00634782553173	GS1	Master Case	15	Not in Commercial Distribution	2019-04-15
Primary	00634782053383	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970211	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Small Adult, 19-23.8cm

Storage Conditions

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