FDA UDI
In Commercial Distribution
🇺🇸 United States
ALARM REPLACEMENT 30-DAY PADS 10/CS
DI: 00733657229097
·
Model: 77665
·
ALIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- ALARM REPLACEMENT 30-DAY PADS 10/CS
- Primary DI
- 00733657229097
- Version / Model
- 77665
- Catalog Number
- 2970010204
- Company Name
- ALIMED, INC.
- Labeler DUNS
- 056007248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 3
- Public Version Date
- 2024-02-26
- Public Version Status
- Update
- Public Device Record Key
- d881d33e-f7ff-40ae-997b-0a336f94f63c
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KMI | MONITOR, BED PATIENT | General Hospital | 880.2400 | 1 |
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 | 00733657229097 | GS1 | ||||
| Unit of Use | 00733657299199 | GS1 |
Customer Contacts
- Phone
- +1(781)329-2900 ext. 0
- [email protected]