FDA UDI
In Commercial Distribution
🇺🇸 United States
GoSafe / HomeSafe Personal Help Wriststrap
DI: 00884838085497
·
Model: 300000267981
·
Lifeline Systems Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GoSafe / HomeSafe Personal Help Wriststrap
- Primary DI
- 00884838085497
- Version / Model
- 300000267981
- Catalog Number
- 7000PHW
- Company Name
- Lifeline Systems Company
- Labeler DUNS
- 080030042
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-01
- Public Version
- 3
- Public Version Date
- 2021-10-19
- Public Version Status
- Update
- Public Device Record Key
- fb932d43-580e-4103-ae00-4ed40a71dea5
Device Description
7000PHW Personal Help Wriststrap
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ILQ | System, communication, powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30087 | Vulnerable patient home alert system | An assembly of electronic devices designed to provide an alarm signal to summon help when activated in response to a patient’s need for urgent assistance or care (e.g., epileptic seizures, falls, low insulin levels). It typically consists of user- or sensor-activated wireless signal transmitters (e.g., patient-worn pendant, wall push-button, fall sensor) and alert communication devices (e.g., network interface, phone, pager). Also known as a personal emergency response system (PERS), it notifies caregivers, neighbours, or emergency medical services (EMS), and is intended for use in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838085497 | GS1 |