FDA UDI
In Commercial Distribution
🇺🇸 United States
Zenex MRI™
DI: 05415067055507
·
Model: PM1283
·
ST. JUDE MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zenex MRI™
- Primary DI
- 05415067055507
- Version / Model
- PM1283
- Catalog Number
- PM1283
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-22
- Public Version
- 1
- Public Version Date
- 2026-01-30
- Public Version Status
- New
- Public Device Record Key
- 17f0a180-3a53-458d-8874-b9399bd139e6
Device Description
SR Pacemaker
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWP | Implantable pulse generator, pacemaker (non-CRT) | Unknown | 3 | |
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47267 | Single-chamber implantable pacemaker, rate-responsive | A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067055507 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140033 | 100 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, keep away from sunlight, Protect from heat and radioactive sources
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius