FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ImPACT
DI: 00864127000301
·
Model: ImPACT
·
IMPACT APPLICATIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImPACT
- Primary DI
- 00864127000301
- Version / Model
- ImPACT
- Company Name
- IMPACT APPLICATIONS, INC.
- Labeler DUNS
- 805665101
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-29
- Public Version
- 4
- Public Version Date
- 2021-03-01
- Public Version Status
- Update
- Public Device Record Key
- ddef2d87-f576-4996-ac54-074f18a63867
- Distribution End Date
- 2021-02-27
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 12-59.
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 |
|---|---|---|---|---|
| 30895 | Cause-and-effect assistive training device | A device designed to be used to assist a person with a disability with developing an understanding of cause and effect (i.e., what is the reason for something to happen and what will be the outcome should it happen). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864127000301 | GS1 |
Customer Contacts
- Phone
- 877-646-7991
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150037 | 000 |