FDA UDI
In Commercial Distribution
🇺🇸 United States
Cubby Beds
DI: 00860007550263
·
Model: KIT10001
·
Sensory Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cubby Beds
- Primary DI
- 00860007550263
- Version / Model
- KIT10001
- Company Name
- Sensory Medical, Inc.
- Labeler DUNS
- 080980318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-31
- Public Version
- 1
- Public Version Date
- 2025-02-10
- Public Version Status
- New
- Public Device Record Key
- 8e00d9f8-8048-499a-a789-be6b3b3fc12c
Device Description
Technology Hub Integrated system with camera, light, sensors, & speaker
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 |
|---|---|---|---|---|
| 64513 | Bedside monitor remote-viewing software, non-physiological parameter | An application software program intended to be used by a healthcare professional to collect, in real-time, non-physiologic data (e.g., intravenous infusion rates, patient mood, patient position) from a bedside monitor (in a healthcare facility or in the home), to facilitate remote patient monitoring, communication, and event notifications for healthcare providers. It is not intended to collect physiological data. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007550263 | GS1 |
Customer Contacts
- Phone
- 855-964-2664
- [email protected]