FDA UDI
In Commercial Distribution
🇺🇸 United States
ENT NIM Vital
DI: 00763000911898
·
Model: NIMCAD400
·
MEDTRONIC XOMED, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ENT NIM Vital
- Primary DI
- 00763000911898
- Version / Model
- NIMCAD400
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-24
- Public Version
- 1
- Public Version Date
- 2024-09-02
- Public Version Status
- New
- Public Device Record Key
- ab5895ad-e928-4861-94f1-1e2e69f02961
Device Description
INTFC ADAPTOR NIMCAD400 NIM 4.0 INCREMT
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
- Yes
- 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 |
|---|---|---|---|---|
| ETN | STIMULATOR, NERVE | Ear, Nose, Throat | 874.1820 | 2 |
| GWF | Stimulator, electrical, evoked response | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64392 | Electrical-only medical device connection adaptor, reusable | A device intended to allow electrical connection of incompatible plugs/sockets on related medical devices (e.g., generator and controller) and/or cables. This device will typically be used when the system components are from different manufacturers or using different technologies, and the original connectors are not compatible; it has no additional non-electrical conduction or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000911898 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200759 | 000 |