FDA UDI
In Commercial Distribution
🇺🇸 United States
OxiWear
DI: 00860008683236
·
Model: OxiV3
·
OXIWEAR, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OxiWear
- Primary DI
- 00860008683236
- Version / Model
- OxiV3
- Catalog Number
- M-001-01
- Company Name
- OXIWEAR, INC.
- Labeler DUNS
- 117449472
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-04
- Public Version
- 1
- Public Version Date
- 2025-06-12
- Public Version Status
- New
- Public Device Record Key
- af5044de-97ac-42e1-88de-e17c26bd68db
Device Description
OxiWear Device and Charger Bundle - Medical - Package of 1
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DPZ | Oximeter, Ear | Cardiovascular | 870.2710 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00860008683236 | GS1 | ||||
| Package | 10860008683233 | GS1 | Case | 25 | In Commercial Distribution | |
| Package | 20860008683230 | GS1 | Case | 50 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233827 | 000 |