FDA UDI
In Commercial Distribution
🇺🇸 United States
NCP® Programming Wand Model 201
DI: 05425025750160
·
Model: 201
·
LIVANOVA USA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NCP® Programming Wand Model 201
- Primary DI
- 05425025750160
- Version / Model
- 201
- Company Name
- LIVANOVA USA, INC.
- Labeler DUNS
- 194568978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 901efd7b-0e72-4e86-84bf-3a12ab41aab6
Device Description
Programming Wand
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MUZ | Stimulator, Autonomic Nerve, Implanted (Depression) | Unknown | 3 | |
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44077 | Vagus nerve electrical stimulation system programmer | A device intended to be used to change, noninvasively, one or more of the operating parameters (the programs) of an implanted stimulator used for vagus nerve stimulation (VNS). It is able to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC will then drive the electronics of the wand to communicate with the implanted stimulation system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05425025750160 | GS1 |
Customer Contacts
- Phone
- 1 (866) 882-8804
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970003 | 016 |
| P970003 | 070 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius