Emprint SX

Basic Information

• Brand Name: Emprint SX
• Primary DI: 10884521703223
• Version / Model: CAFG1
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-13
• Public Version: 6
• Public Version Date: 2022-05-06
• Public Version Status: Update
• Public Device Record Key: c5cc2928-3287-43bf-b49a-63f8e8a15ef6

Device Description

Field Generator

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: Yes
• Has Lot/Batch Number: No
• 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
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES	General, Plastic Surgery	878.4400	2
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58138	Non-evacuated blood collection tube IVD, clot activator/separator	A non-evacuated glass or plastic tube, sealed with a stopper, containing a clot activator and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521703223	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity