Pulmonary Hygiene Kit

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Pulmonary Hygiene Kit FDA UDI
Generic Name: Inhalation therapy saline solution, isotonic FDA UDI
Device Name: 1 - Circulaire II Hybrid Aerosol Drug Delivery System and 6 - 4ml PulmoSal Vials FDA UDI
Model / Reference: 0393R-10 FDA UDI
Description: 1 - Circulaire II Hybrid Aerosol Drug Delivery System and 6 - 4ml PulmoSal Vials FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078002106 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nebulizing system delivery set, single-use Inhalation therapy saline solution, isotonic

Pulmonary Hygiene Kit by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Inhalation therapy saline solution, isotonic.

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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

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: Westmed, Inc.

Sources (1)

FDA UDI eeb21300-c253-4d5f-b2e4-34f79ccbfaf0 33 fields · synced May 30, 2026