Identity
- Trade Name
- HUDSON RCI FDA UDI
- Generic Name
- Inhalation therapy sterile water FDA UDI
- Device Name
- CONCHA Sterile Water, 1650 mL FDA UDI
- Model / Reference
- IPN049211 FDA UDI
- Description
- CONCHA Sterile Water, 1650 mL FDA UDI
Identifiers
- Catalog Number
- 381-50 FDA UDI
- Primary DI / UDI-DI
- 14026704628183 FDA UDI
- 510(k) Number
- K760866 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Inhalation therapy sterile water 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Inhalation therapy sterile water
Hudson Rci by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inhalation therapy sterile water.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- AMSure® Sterile Water for Inhalation, USP Prefilled Humidifier, 350mL — AMSINO INTERNATIONAL, INC. · Class II
- AMSure® Sterile Water for Inhalation, USP 1000mL — AMSINO INTERNATIONAL, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K760866 also covers:
- 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
- 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
- Teleflex Incorporated
Sources (1)
- FDA UDI b9faa762-50de-43ae-93cb-bc5e9fc5e859 36 fields · synced Jun 6, 2026