FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00763000571528
·
Model: 5019
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00763000571528
- Version / Model
- 5019
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-30
- Public Version
- 3
- Public Version Date
- 2024-05-06
- Public Version Status
- Update
- Public Device Record Key
- 0f5f69a0-9db7-4d8a-a8fe-0ac92c39d8c1
Device Description
SPLITTER 5019 M-4 HV GLBL
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
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 | |
| NVY | Permanent defibrillator electrodes | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45850 | Pacing/defibrillation lead electrical extension adaptor | An implantable device used to provide a functional and modified connection between existing pacing leads (e.g., IS-1 leads) and an implantable pacing/defibrillation device (e.g., pacemaker, defibrillator). It typically consists of a small connector block to enable attachment to the pacing leads (i.e., when they do not meet connection design) and extension leads to increase the reach of the pacing leads. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination. This device facilitates the implantation of the pacing device and/or is useful if two leads need to be implanted. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000571528 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit