FDA UDI
In Commercial Distribution
🇺🇸 United States
Merlin™
DI: 05415067049575
·
Model: MLC1000
·
ST. JUDE MEDICAL, INC.
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Merlin™
- Primary DI
- 05415067049575
- Version / Model
- MLC1000
- Catalog Number
- MLC1000
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-25
- Public Version
- 1
- Public Version Date
- 2025-07-03
- Public Version Status
- New
- Public Device Record Key
- be321df1-63e1-4b20-aa1f-1e4f95a19b47
Device Description
Live Connect Remote Session Engine
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 |
|---|---|---|---|---|
| OSR | Pacemaker/icd/crt non-implanted components | Unknown | 3 | |
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) | Unknown | 3 | |
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 | |
| DXY | implantable pacemaker Pulse-generator | Cardiovascular | 870.3610 | 3 |
| LWO | Pulse-generator, single chamber, sensor driven, implantable | Unknown | 3 | |
| LWP | Implantable pulse generator, pacemaker (non-CRT) | Unknown | 3 | |
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067049575 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]