Identity
- Trade Name
- HUDSON RCI FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- RIGHT ANGLE STRAIGHT TEMP PROBE,10K FDA UDI
- Model / Reference
- IPN044269 FDA UDI
- Description
- RIGHT ANGLE STRAIGHT TEMP PROBE,10K FDA UDI
Identifiers
- Catalog Number
- 380-91 FDA UDI
- Primary DI / UDI-DI
- 04026704396146 FDA UDI
- 510(k) Number
- K881625 FDA UDI
- FDA Product Code
- BZE FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5270 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
MR Unsafe FDA UDI
Category: Heated respiratory humidifier
Hudson Rci by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heated respiratory humidifier.
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- REMstar — Respironics, Inc. · Class II
- System One — Respironics, Inc. · Class II
Cleared under the same submission
K881625 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 5ff4d41e-19c5-4664-a5c1-9652c5a42b42 36 fields · synced May 30, 2026