BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

QUANTIEN™

DI: 05415067004635 · Model: Measurement System · ST. JUDE MEDICAL, INC.

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Product Codes

2

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: QUANTIEN™
Primary DI: 05415067004635
Version / Model: Measurement System
Catalog Number: C12797
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: 2
Public Version Date: 2018-03-29
Public Version Status: Update
Public Device Record Key: 5ca239d6-44c0-47c6-a4a0-8583dde27cfa

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
43621	Desk mount	A non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067004635	GS1

Customer Contacts

Phone: +1(855)478-5833
Email: [email protected]

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Keep dry. Do not use is package is damaged.
Type: Handling Environment Temperature
Temperature Range: -20 – 70 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: -4 – 158 Degrees Fahrenheit
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: -20 – 70 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -4 – 158 Degrees Fahrenheit