Identity
- Trade Name
- HUDSON RCI FDA UDI
- Generic Name
- Inhalation therapy saline solution, isotonic FDA UDI
- Device Name
- AQUAPAK LVN,STRL WATER,760ML,W/ 33 ADAPT FDA UDI
- Model / Reference
- HUD03733 FDA UDI
- Description
- AQUAPAK LVN,STRL WATER,760ML,W/ 33 ADAPT FDA UDI
Identifiers
- Catalog Number
- HUD03733 FDA UDI
- Primary DI / UDI-DI
- 20197344007223 FDA UDI
- 510(k) Number
- K141214 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Inhalation therapy saline solution, isotonic 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
Yes
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
Yes
FDA UDI
Category: Inhalation therapy sterile waterInhalation therapy saline solution, isotonic
Hudson Rci by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inhalation therapy saline solution, isotonic.
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Sodium Chloride Inhalation Solution, USP, 0.9%-3mL — LIFESTAR PHARMA LLC · Class II
- Sodium Chloride Inhalation Solution, USP 0.9% — Nephron Pharmaceuticals Corp. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K141214 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 — 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 — MEDLINE INDUSTRIES, INC.
- HUDSON RCI — MEDLINE INDUSTRIES, INC.
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 1a297f83-78c9-498b-a951-15d2b535575f 37 fields · synced Jun 7, 2026