Breathe Comfort

FDA UDI

Class II (US FDA UDI)

by Slv Pharmaceuticals LLC

Identity

Trade Name: BREATHE COMFORT FDA UDI
Generic Name: Medicine chamber spacer, reusable FDA UDI
Device Name: BREATHE COMFORT OPTICHAMBERS - ADULT FDA UDI
Model / Reference: OPTICHAMBERS FDA UDI
Description: BREATHE COMFORT OPTICHAMBERS - ADULT FDA UDI

Identifiers

Primary DI / UDI-DI: 00373317495228 FDA UDI
FDA Product Code: NVP FDA UDI
GMDN Term: Medicine chamber spacer, reusable 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

FDA UDI

Implantable

FDA UDI

Contains Latex

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Medicine chamber spacer, reusable

Breathe Comfort by Slv Pharmaceuticals LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Slv Pharmaceuticals LLC

Sources (1)

FDA UDI efefee0b-67bd-4a68-aa9d-9421655f1647 33 fields · synced Jun 8, 2026