FDA UDI
In Commercial Distribution
🇺🇸 United States
PAGER, SCOPE GEOALPHA
DI: 00812664024106
·
Model: NC397A
·
Securitas Healthcare LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PAGER, SCOPE GEOALPHA
- Primary DI
- 00812664024106
- Version / Model
- NC397A
- Catalog Number
- NC397A
- Company Name
- Securitas Healthcare LLC
- Labeler DUNS
- 079758354
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-10
- Public Version
- 3
- Public Version Date
- 2024-02-29
- Public Version Status
- Update
- Public Device Record Key
- 4043277a-d193-444a-ac60-30c4047284ae
Device Description
PAGER, SCOPE GEOALPHA
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IQA | SYSTEM, ENVIRONMENTAL CONTROL, POWERED | Physical Medicine | 890.3725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44341 | Phone/pager | A telecommunication device intended to receive messages/calls from a nurse call or home alert system device (e.g., ambulatory fall sensor, wall-affixed push-button) to notify a recipient that (urgent) assistance is required by the patient; it is also used with some long-session therapeutic devices (e.g., cryolipolysis skin contouring system) to send reminders to the operator during treatment. It alerts the recipient with an audio, tactile, and/or visual signal and is typically used by medical professionals, caregivers or neighbours responsible for the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812664024106 | GS1 |
Customer Contacts
- Phone
- +1(800)380-8883
- [email protected]