Identity
- Trade Name
- HUDSON RCI FDA UDI
- Generic Name
- Oxygen administration/humidifier set FDA UDI
- Device Name
- AQUAPAK ADAPTER,ALARM,ADAPTER ONLY FDA UDI
- Model / Reference
- HUD00040 FDA UDI
- Description
- AQUAPAK ADAPTER,ALARM,ADAPTER ONLY FDA UDI
Identifiers
- Catalog Number
- HUD00040 FDA UDI
- Primary DI / UDI-DI
- 10197344007479 FDA UDI
- 510(k) Number
- K141353 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Oxygen administration/humidifier set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 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: Oxygen administration/humidifier set
Hudson Rci by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen administration/humidifier set.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K141353 also covers:
- HUDSON RCI — MEDLINE INDUSTRIES, INC.
- HUDSON RCI — MEDLINE INDUSTRIES, INC.
- HUDSON RCI — MEDLINE INDUSTRIES, INC.
- HUDSON RCI — MEDLINE INDUSTRIES, INC.
- HUDSON RCI — MEDLINE INDUSTRIES, INC.
- HUDSON RCI — TELEFLEX INCORPORATED
- HUDSON RCI — TELEFLEX INCORPORATED
- HUDSON RCI — TELEFLEX INCORPORATED
- HUDSON RCI — TELEFLEX INCORPORATED
- HUDSON RCI — TELEFLEX INCORPORATED
- HUDSON RCI — TELEFLEX INCORPORATED
- HUDSON RCI — TELEFLEX INCORPORATED
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 6239bd41-e5e0-47af-b304-197eec4a2ed4 36 fields · synced Jun 8, 2026