FDA UDI
In Commercial Distribution
🇺🇸 United States
Nitron CryoConsole™
DI: 00763000593902
·
Model: NITRON
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Nitron CryoConsole™
- Primary DI
- 00763000593902
- Version / Model
- NITRON
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-15
- Public Version
- 1
- Public Version Date
- 2024-02-23
- Public Version Status
- New
- Public Device Record Key
- 4aff3671-02dc-41b6-9a93-3e37a0999d43
Device Description
CONSOLE NITRON US
Device Characteristics
- Single Use
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPB | Cardiac ablation percutaneous catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60721 | Cardiac cryosurgical system | A mobile assembly of mains electricity (AC-powered) devices intended to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It typically includes a console, monitor, connection cable(s), electrocardiogram (ECG) electrodes, and a cryoablation catheter in which extremely low temperatures are achieved through expansion of a pressurized liquid refrigerant (e.g., nitrous oxide) at the catheter tip; monitoring is achieved via ECG displays and sensors within the catheter. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000593902 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P020045 | 105 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry