FDA UDI
In Commercial Distribution
🇺🇸 United States
Micra™
DI: 00643169529748
·
Model: MC1VR01US
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Micra™
- Primary DI
- 00643169529748
- Version / Model
- MC1VR01US
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-18
- Public Version
- 9
- Public Version Date
- 2021-07-21
- Public Version Status
- Update
- Public Device Record Key
- 8292c61a-afcc-42c2-8a3d-a0460ea2953e
Device Description
TRANSCATH PACE SYS MC1VR01US MICRA US
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PNJ | Leadless pacemaker | Cardiovascular | 870.3610 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60789 | Intracardiac pacemaker | A battery-powered, hermetically-sealed pulse generator impregnated with a steroid (e.g., dexamethasone) intended to be implanted with a catheter, via transvenous access, into the right ventricle (i.e., single-chamber pacing) of an arrhythmic heart to generate/conduct electrical impulses to improve cardiac output. It contains sensors to detect changes in the body (e.g., motion, breathing frequency) and to adjust the pacing rate accordingly (rate-responsive). Wireless telemetry with external devices enables programming adjustments and may allow on-going heart monitoring; it does not provide defibrillation therapy. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169529748 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150033 | 000 |
| P150033 | 003 |
| P150033 | 051 |
| P150033 | 059 |
| P150033 | 077 |
| P150033 | 090 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Size 23 Fr | ||
| Length | 105.0 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 77 – 77 Degrees Fahrenheit