FDA UDI
In Commercial Distribution
🇺🇸 United States
Analytic for Hemodynamic Instability
DI: B823AHIP100
·
Model: P1
·
Fifth Eye, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Analytic for Hemodynamic Instability
- Primary DI
- B823AHIP100
- Version / Model
- P1
- Company Name
- Fifth Eye, Inc.
- Labeler DUNS
- 081336754
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-10
- Public Version
- 4
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- bd099ea1-fab5-4697-9677-9c8a3069869d
Device Description
Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| QNV | Adjunctive Hemodynamic Indicator With Decision Point | Cardiovascular | 870.2220 | 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 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, referral pathways, 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. Also 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 | B823AHIP100 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200022 | 000 |