FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlas Sensor
DI: 00860008806024
·
Model: Rev A
·
Atlas Lift Tech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Atlas Sensor
- Primary DI
- 00860008806024
- Version / Model
- Rev A
- Company Name
- Atlas Lift Tech, Inc.
- Labeler DUNS
- 034561315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 2
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 3b520ca9-9c06-49ac-905e-0b5d1257db6f
Device Description
A reusable, wireless, Bluetooth device that sends patient body orientation and movement information to the Bedside Mobility Monitor (BMM) that is housed within the Atlas Wearable Patch.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 65832 | Wireless patient monitor/sensor reporting software, professional-only | A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008806024 | GS1 |