Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Finger Tip Pulse Oximeter (Includes 2 AAA Batteries) w/Neck Strap, O&M Manual, Carry Case. FDA UDI
- Model / Reference
- 00-632 FDA UDI
- Description
- Finger Tip Pulse Oximeter (Includes 2 AAA Batteries) w/Neck Strap, O&M Manual, Carry Case. FDA UDI
Identifiers
- Catalog Number
- 00-632 FDA UDI
- Primary DI / UDI-DI
- B005006320 FDA UDI
- 510(k) Number
- K070371 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter
AincA® by Anesthesia Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070371 also covers:
- AincA® — Anesthesia Associates, Inc.
- Pulse Oximeter — Dynarex Corp.
- Pulse Oximeter — Dynarex Corp.
- Fingertip Pulse Oximeter — O-Two Medical Technologies Inc
- ri-fox N, pulse oximeter — Rudolf Riester GmbH & Co. KG
- SPO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor Adapter Cable — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor Adapter Cable — SUNSET HEALTHCARE SOLUTIONS, Inc.
- SpO2 Sensor Adapter Cable — SUNSET HEALTHCARE SOLUTIONS, Inc.
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
- Anesthesia Associates, Inc.
Sources (1)
- FDA UDI c4178cf8-cd08-4c7b-b62d-4698a4d6661f 36 fields · synced May 30, 2026