FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxxiom
DI: B944TWPD1DA0320150
·
Model: 1612
·
TRUE WEARABLES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxxiom
- Primary DI
- B944TWPD1DA0320150
- Version / Model
- 1612
- Catalog Number
- TWPD1DA032015
- Company Name
- TRUE WEARABLES, INC.
- Labeler DUNS
- 080108600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-10
- Public Version
- 2
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- ce4ac030-2c01-4bb9-8a2a-b0ae9fe89f23
Device Description
Wireless, Disposable, Single-Use Pulse Oximetry System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45607 | Pulse oximeter | An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B944TWPD1DA0320150 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200537 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- – 60 Percent (%) Relative Humidity