QUANTIEN™

Basic Information

• Brand Name: QUANTIEN™
• Primary DI: 05415067004642
• Version / Model: C12798
• Catalog Number: C12798
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-14
• Public Version: 3
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 6c2dff5c-216a-4652-a71f-8971c2848cd8

Device Description

Mounting Bracket

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: 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
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE	Cardiovascular	870.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32245	Medical monitor/light mount	A permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067004642	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Do not use if the package is damaged.
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 158 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -4 – 158 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius