FDA UDI
In Commercial Distribution
🇺🇸 United States
Smart Caregiver
DI: 00812293016350
·
Model: DTP-PRB
·
Smart Caregiver Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Smart Caregiver
- Primary DI
- 00812293016350
- Version / Model
- DTP-PRB
- Company Name
- Smart Caregiver Corporation
- Labeler DUNS
- 012082397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-23
- Public Version
- 1
- Public Version Date
- 2022-05-31
- Public Version Status
- New
- Public Device Record Key
- 226ffc7f-aae7-470e-be8e-8f47981599dc
Device Description
Pager
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 |
|---|---|---|---|---|
| KMI | Monitor, Bed Patient | General Hospital | 880.2400 | 1 |
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 | 00812293016350 | GS1 |