FDA UDI
In Commercial Distribution
🇺🇸 United States
AWARE DART iOS Client
DI: 00850893007033
·
Model: 1.0
·
AMBIENT CLINICAL ANALYTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AWARE DART iOS Client
- Primary DI
- 00850893007033
- Version / Model
- 1.0
- Company Name
- AMBIENT CLINICAL ANALYTICS, INC.
- Labeler DUNS
- 080221585
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-03
- Public Version
- 5
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- f8407987-eb17-4d84-b68d-bccaf12c35ed
Device Description
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61087 | Clinical management support software | An application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850893007033 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143372 | 000 |