FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultium
DI: 00816271020001
·
Model: 873
·
Noraxon U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ultium
- Primary DI
- 00816271020001
- Version / Model
- 873
- Company Name
- Noraxon U.S.A., Inc.
- Labeler DUNS
- 611243809
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-06
- Public Version
- 1
- Public Version Date
- 2021-05-14
- Public Version Status
- New
- Public Device Record Key
- 20e38c44-e21f-413b-8e72-352034fae132
Device Description
Ultium Sensor Charger
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KQX | Goniometer, Ac-Powered | Orthopedic | 888.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63313 | Kinesiology/electromyographic sensor set | A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816271020001 | GS1 |
Customer Contacts
- Phone
- 4804433413
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius