FDA UDI
In Commercial Distribution
🇺🇸 United States
Reveal LINQ™
DI: 00763000562625
·
Model: LNQ11
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reveal LINQ™
- Primary DI
- 00763000562625
- Version / Model
- LNQ11
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-04
- Public Version
- 1
- Public Version Date
- 2021-09-13
- Public Version Status
- New
- Public Device Record Key
- 838dd49a-dcda-4d5a-beac-cc08f9d5b803
Device Description
MON LNQ11 REVEAL LINQ USA
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSI | DETECTOR AND ALARM, ARRHYTHMIA | Cardiovascular | 870.1025 | 2 |
| MXD | Recorder, event, implantable cardiac, (with arrhythmia detection) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47804 | Implantable cardiac monitor | A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000562625 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212008 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius