Identity
- Trade Name
- PulmoSal 7% (pH+) FDA UDI
- Generic Name
- Inhalation therapy saline solution, hypertonic FDA UDI
- Device Name
- Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic FDA UDI
- Model / Reference
- 74060 FDA UDI
- Description
- Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic FDA UDI
Identifiers
- Catalog Number
- 50190-740-60 FDA UDI
- Primary DI / UDI-DI
- 40850877007033 FDA UDI
- 510(k) Number
- K130091 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
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Inhalation therapy saline solution, hypertonic
PulmoSal 7% (pH+) by Pharmacaribe Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inhalation therapy saline solution, hypertonic.
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- 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
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
- Pharmacaribe Llc
Sources (1)
- FDA UDI 8dfc3710-fa57-44c4-9115-20b7da3cec28 38 fields · synced Jun 6, 2026