Identity
- Trade Name
- Saline FDA UDI
- Generic Name
- Inhalation therapy saline solution, hypertonic FDA UDI
- Device Name
- 7% Hypertonic Saline FDA UDI
- Model / Reference
- 300F7010 FDA UDI
- Description
- 7% Hypertonic Saline FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00744229307600 FDA UDI
- 510(k) Number
- K070498 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
Saline by Pari Respiratory Equipment, 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
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Sodium Chloride Inhalation Solution, USP 3% — Nephron Pharmaceuticals Corp. · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV — RITEDOSE PHARMACEUTICALS, LLC · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · 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
K070498 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
- Pari Respiratory Equipment, Inc.
Sources (1)
- FDA UDI 051941c8-709c-4ec4-9026-8725af4c774e 34 fields · synced May 29, 2026