FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuropack S3
DI: 00841983104251
·
Model: NPS3-LT-Cart2-ZA
·
NIHON KOHDEN AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neuropack S3
- Primary DI
- 00841983104251
- Version / Model
- NPS3-LT-Cart2-ZA
- Catalog Number
- MEB-9600
- Company Name
- NIHON KOHDEN AMERICA, INC.
- Labeler DUNS
- 021063219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-20
- Public Version
- 2
- Public Version Date
- 2023-10-09
- Public Version Status
- Update
- Public Device Record Key
- fc89495f-db0c-43b0-87ec-49c9fc6cc95f
Device Description
Preassembled MEB-9600 on Cart for MEB-9600 Neuropack S3 desktop system, performs Evoked potentials, nerve conduction and electromyography studies
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| IKN | Electromyograph, diagnostic | Physical Medicine | 890.1375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11614 | Evoked-potential graphic recording system | An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841983104251 | GS1 |
Customer Contacts
- Phone
- +1(800)325-0283
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010590 | 000 |