Identity
- Trade Name
- RD SET FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- RD SET DBI Adult Soft Reusable Sensor FDA UDI
- Model / Reference
- 4052 FDA UDI
- Description
- RD SET DBI Adult Soft Reusable Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843997014298 FDA UDI
- 510(k) Number
- K113596 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable 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
Yes
FDA UDI
Category: Pulse oximeter probe, reusable
Rd Set by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- APK — Apk Technology · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K113596 also covers:
- MasimoSET DBI-dc3 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- MasimoSET DBI-dc8 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- MasimoSET M-LNCS Multisite-L Reusable Sensor — MASIMO CORPORATION
- MasimoSET® LNCS® DBI SpO2 Adult Soft Reusable Sensor — MASIMO CORPORATION
- MasimoSET® Red DBI-dc3 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
- MasimoSET® Red DBI-dc8 SpO2 Adult Reusable Sensor — MASIMO CORPORATION
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 8f740dc9-793f-497d-98a6-77e6f6024446 36 fields · synced Jun 6, 2026