Identity
- Trade Name
- HUDSON RCI FDA UDI
- Generic Name
- Inhalation therapy sterile water FDA UDI
- Device Name
- ADDIPAK SW 3 ML FDA UDI
- Model / Reference
- IPN916685 FDA UDI
- Description
- ADDIPAK SW 3 ML FDA UDI
Identifiers
- Catalog Number
- RHUD31U FDA UDI
- Primary DI / UDI-DI
- 14026704717771 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Inhalation therapy sterile water FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
Yes
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
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 5c17b68c-c8ee-43d3-a8cd-e74cc29de92f 35 fields · synced May 30, 2026