FDA UDI
In Commercial Distribution
🇺🇸 United States
MedtronicLongevity
DI: 00643169713697
·
Model: MDTLONG
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MedtronicLongevity
- Primary DI
- 00643169713697
- Version / Model
- MDTLONG
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-22
- Public Version
- 3
- Public Version Date
- 2023-11-06
- Public Version Status
- Update
- Public Device Record Key
- e61bf0c7-a752-4c48-956d-f721df82ed4b
Device Description
SW MDTLONG MEDTRONICLONGEVITY
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 | |
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66997 | Active implantable device longevity estimation software | An application software program intended to be used on a non-medical computerized device (e.g., tablet, laptop) to estimate the longevity of an active implantable device based on elements such as model type, implantation date, and data extracted from external implant readers/programmers. It is intended to be used by a clinician to assist clinicians in ongoing patient care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169713697 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]