Identity
- Trade Name
- BluSat FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Gentle Touch Neonatal Fabric Sensor FDA UDI
- Model / Reference
- 4344 FDA UDI
- Description
- Gentle Touch Neonatal Fabric Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30859998006331 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulse oximeter probe, single-use
BluSat by Osi Optoelectronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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- 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
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
- Osi Optoelectronics, Inc.
Sources (1)
- FDA UDI 01535f22-327c-4db7-9c1d-3731498c10b5 33 fields · synced May 29, 2026