FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Wearable Patch Shelf Box
DI: 01968523766980
·
Model: Rev A
·
Atlas Lift Tech, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
15
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Wearable Patch Shelf Box
- Primary DI
- 01968523766980
- Version / Model
- Rev A
- Company Name
- Atlas Lift Tech, Inc.
- Labeler DUNS
- 034561315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2022-12-23
- Public Version
- 2
- Public Version Date
- 2024-04-03
- Public Version Status
- Update
- Public Device Record Key
- f28ff16e-819e-4694-af7d-5633482aede1
- Distribution End Date
- 2024-01-31
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 12391 | Wearable multiple physiological parameter recorder, reusable | An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 21968523766984 | GS1 | shipper box | 240 | Not in Commercial Distribution | 2024-01-31 |
| Primary | 01968523766980 | GS1 | ||||
| Unit of Use | 11968523766987 | GS1 |