AccessGUDID - DEVICE: Merlin™ (05414734509725)

GUDID

Device Identifier (DI) Information

Brand Name: Merlin™
Version or Model: 3330
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3330
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734509725
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Software Upgrade Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61680	Implantable cardiac device management application software	An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
NVZ	Pulse generator, permanent, implantable
LWS	Implantable cardioverter defibrillator (non-CRT)
OSR	Pacemaker/icd/crt non-implanted components
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
DXY	implantable pacemaker Pulse-generator
LWP	Implantable pulse generator, pacemaker (non-CRT)
LWO	Pulse-generator, single chamber, sensor driven, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 409fbc62-d6e7-40c2-9a51-8be6a805bee2
Public Version Date: July 27, 2023
Public Version Number: 6
DI Record Publish Date: January 27, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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