Identity
- Trade Name
- Oxxiom FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Wireless, Disposable, Single-Use Pulse Oximetry System FDA UDI
- Model / Reference
- 1612 FDA UDI
- Description
- Wireless, Disposable, Single-Use Pulse Oximetry System FDA UDI
Identifiers
- Catalog Number
- TWPD1DA032015 FDA UDI
- Primary DI / UDI-DI
- B944TWPD1DA0320150 FDA UDI
- 510(k) Number
- K200537 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Pulse oximeter
Oxxiom by True Wearables, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- True Wearables, Inc.
Sources (1)
- FDA UDI ce4ac030-2c01-4bb9-8a2a-b0ae9fe89f23 36 fields · synced May 29, 2026