FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambra Health Mobile Application
DI: AMBRMOBILEAPP0
·
Model: AMBRMOBILEAPP0
·
Ambra Health
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ambra Health Mobile Application
- Primary DI
- AMBRMOBILEAPP0
- Version / Model
- AMBRMOBILEAPP0
- Company Name
- Ambra Health
- Labeler DUNS
- 012054504
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-01
- Public Version
- 2
- Public Version Date
- 2023-08-30
- Public Version Status
- Update
- Public Device Record Key
- 76e7e4a5-537a-4891-90d8-a1684386fec4
Device Description
Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
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
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17175 | Radiology information system | A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | AMBRMOBILEAPP0 | HIBCC |
Customer Contacts
- Phone
- 888-315-0790
- [email protected]