FDA UDI
In Commercial Distribution
🇺🇸 United States
Elite Digital
DI: B484DARPSM50050
·
Model: DARPSM5005
·
Crest Healthcare Supply
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elite Digital
- Primary DI
- B484DARPSM50050
- Version / Model
- DARPSM5005
- Catalog Number
- N/A
- Company Name
- Crest Healthcare Supply
- Labeler DUNS
- 151772415
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-11
- Public Version
- 1
- Public Version Date
- 2024-10-21
- Public Version Status
- New
- Public Device Record Key
- c4fa1e22-e140-4521-92ab-fdcb2399cb82
Device Description
PILLOW SPEAKER, ELITE DIGITAL, CRITICAL ALERT, OEM, NURSE CALL, PAIN TOILET WATER BUTTONS, VIRTUAL NURSE,10 KEY
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
- 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 |
|---|---|---|---|---|
| IQA | System, Environmental Control, Powered | Physical Medicine | 890.3725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62165 | Nurse call system | An assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B484DARPSM50050 | HIBCC |
Customer Contacts
- Phone
- 1-320-275-3382
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Feet |