SootheNeb

FDA UDI

Class II (US FDA UDI)

by Fora Care Inc.

Identity

Trade Name: SootheNeb FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: Compressor Nebulizer FDA UDI
Model / Reference: NBL200 FDA UDI
Description: Compressor Nebulizer FDA UDI

Identifiers

Primary DI / UDI-DI: 00816042011153 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

SootheNeb by Fora Care Inc. — 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: Fora Care Inc.

Sources (1)

FDA UDI 0b154688-8eb4-4e1e-9ce0-e4c6c226f064 33 fields · synced Jun 1, 2026