Identity
- Trade Name
- Rad-97 FDA UDI
- Generic Name
- Pulse Co-oximeter FDA UDI
- Device Name
- Home Use with noninvasive blood pressure, and camera FDA UDI
- Model / Reference
- 9785 FDA UDI
- Description
- Home Use with noninvasive blood pressure, and camera FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997014281 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse Co-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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse Co-oximeter
Rad-97 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse Co-oximeter.
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- Radius-7 — MASIMO CORPORATION · Class II
- Radius-7 — MASIMO CORPORATION · Class II
- Radius-PPG — MASIMO CORPORATION · Class II
- Rad-97 — MASIMO CORPORATION · Class II
- Rad-97 — MASIMO CORPORATION · Class II
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
- Masimo Corporation
Sources (1)
- FDA UDI d9e17bc6-4df6-4060-923b-936cc18b466a 35 fields · synced Jun 6, 2026