FDA UDI
In Commercial Distribution
🇺🇸 United States
ARIAL
DI: 00840948101915
·
Model: 2560-59361
·
Securitas Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ARIAL
- Primary DI
- 00840948101915
- Version / Model
- 2560-59361
- Catalog Number
- 2560-59361
- Company Name
- Securitas Healthcare LLC
- Labeler DUNS
- 079758354
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-13
- Public Version
- 1
- Public Version Date
- 2024-06-21
- Public Version Status
- New
- Public Device Record Key
- aabc210b-24ab-4e8b-b2a9-8292fe1cf0d6
Device Description
Arial Wireless Water-Resistant Pendant ES with Wristband
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
- 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 |
|---|---|---|---|---|
| 62166 | Ambulatory call button | A battery-powered electronic switch intended to be carried by a patient (e.g., in the form of a patch, pendant, wristband) to initiate an alert signal for help when manually activated by the patient in need of assistance (e.g., general care, epileptic seizures, falls, low insulin levels). It typically consists of a push-button wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., central server, telephone, 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 | 00840948101915 | GS1 |
Customer Contacts
- Phone
- +1(800)380-8883
- [email protected]