Breathe Comfort

FDA UDI

Class I (US FDA UDI)

by Slv Pharmaceuticals LLC

Identity

Trade Name: BREATHE COMFORT FDA UDI
Generic Name: Nasal irrigation set, home-use FDA UDI
Device Name: Breathe Comfort Nasal Irrigator FDA UDI
Model / Reference: NASAL IRRIGATOR FDA UDI
Description: Breathe Comfort Nasal Irrigator FDA UDI

Identifiers

Primary DI / UDI-DI: 00850024759138 FDA UDI
FDA Product Code: KMA FDA UDI
GMDN Term: Nasal irrigation set, home-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nasal irrigation set, home-use

Breathe Comfort by Slv Pharmaceuticals LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Slv Pharmaceuticals LLC

Sources (1)

FDA UDI 38de3e8b-4dd7-4e0d-aa3f-c33fceb9680c 33 fields · synced May 31, 2026