FDA UDI
In Commercial Distribution
🇺🇸 United States
ARIAL
DI: 00840948102721
·
Model: 54390
·
Securitas Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARIAL
- Primary DI
- 00840948102721
- Version / Model
- 54390
- Catalog Number
- 54390
- Company Name
- Securitas Healthcare LLC
- Labeler DUNS
- 079758354
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 2
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 61ff6a35-d392-4b6c-b4f2-b41055f376b0
Device Description
Arial Software Client w/ Desktop PC Bundle
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| IQA | System, environmental control, powered | Physical Medicine | 890.3725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62167 | Fixed call button | A battery-powered electronic switch intended to initiate an alert signal for help when manually activated by a user in response to a need of assistance (e.g., general care, low insulin levels). It typically consists of a bedside, wall-affixed, push-button or pull-cord, wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., central server, phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that assistance is needed. It is intended to be used in the home and healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840948102721 | GS1 |
Customer Contacts
- Phone
- +1(800)380-8883
- [email protected]