Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Inhalation therapy saline solution, hypertonic FDA UDI
- Device Name
- FDA Class N/A Import Latex Free Physician Formulary Sterile FDA UDI
- Model / Reference
- UD9003 FDA UDI
- Description
- FDA Class N/A Import Latex Free Physician Formulary Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30885632127629 FDA UDI
- 510(k) Number
- K820227 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Inhalation therapy saline solution, hypertonic 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
No
FDA UDI
Category: Inhalation therapy saline solution, hypertonic
MediChoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inhalation therapy saline solution, hypertonic.
- Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV — RITEDOSE PHARMACEUTICALS, LLC · Class II
- Hyper-Sal — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- Saline — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Sodium Chloride Inhalation Solution, USP 3% — Nephron Pharmaceuticals Corp. · Class II
- Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV — RITEDOSE PHARMACEUTICALS, LLC · Class II
- Sodium Chloride Inhalation Solution, USP, 3.5% 4mL UDV — RITEDOSE PHARMACEUTICALS, LLC · Class II
- Sodium Chloride Inhalation Solution, USP 0.9% 5mL — MYLAN PHARMACEUTICALS INC. · Class II
Cleared under the same submission
K820227 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 |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 6af92673-35b8-49d1-be2f-04fe25ff7aba 34 fields · synced May 30, 2026