FDA UDI
In Commercial Distribution
🇺🇸 United States
ImPACT Version 4
DI: 00864127000349
·
Model: 4
·
IMPACT APPLICATIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImPACT Version 4
- Primary DI
- 00864127000349
- Version / Model
- 4
- Company Name
- IMPACT APPLICATIONS, INC.
- Labeler DUNS
- 805665101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-27
- Public Version
- 1
- Public Version Date
- 2021-03-08
- Public Version Status
- New
- Public Device Record Key
- 7701f610-cfdd-4212-817f-e04677a7ea55
Device Description
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
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
- No
- 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 |
|---|---|---|---|---|
| POM | Computerized Cognitive Assessment Aid For Concussion | Neurology | 882.1471 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63185 | Cognitive assessment software | A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864127000349 | GS1 |
Customer Contacts
- Phone
- 877-646-7991
- [email protected]