Identity
- Trade Name
- Soft Sensor Medium WO2 Model 8000SM-WO2 FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Model 8000SM-WO2, Soft Sensor Medium WO2, Philips, Reusable Pulse Oximetry Soft Sensor FDA UDI
- Model / Reference
- 8000SM-WO2 FDA UDI
- Description
- Model 8000SM-WO2, Soft Sensor Medium WO2, Philips, Reusable Pulse Oximetry Soft Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849686051001 FDA UDI
- 510(k) Number
- K092101 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter probe, single-use 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
MR Unsafe FDA UDI
Category: Pulse oximeter probe, reusablePulse oximeter probe, single-use
Soft Sensor Medium WO2 Model 8000SM-WO2 by Nonin Medical, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
- APK — Apk Technology · Class II
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- MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
- Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
- M-LNCS — MASIMO CORPORATION · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nonin Medical, Inc.
Sources (2)
- FDA UDI a471650b-48a6-4579-9902-170e456654c2 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026