BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Merlin™

DI: 05414734503136 · Model: EX3180 · ST. JUDE MEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Merlin™
Primary DI: 05414734503136
Version / Model: EX3180
Catalog Number: EX3180
Company Name: ST. JUDE MEDICAL, INC.
Labeler DUNS: 790268031
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2014-09-30
Public Version: 6
Public Version Date: 2023-10-05
Public Version Status: Update
Public Device Record Key: 155aefa7-7550-4e1c-b416-5edb5f418417

Device Description

Adapter Medtronic Patient Cable Model 2292

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
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
31700	External pacemaker analyser	An electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734503136	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	10	Inch

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -10 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 14 – 122 Degrees Fahrenheit
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: 14 – 122 Degrees Fahrenheit