Ventlab

FDA UDI

Class II (US FDA UDI)

by Ventlab Corp.

Identity

Trade Name: Ventlab FDA UDI
Generic Name: Atomizer, non-ventilatory FDA UDI
Device Name: Anti-Static Spacer /Infant Mask FDA UDI
Model / Reference: HCSA112 FDA UDI
Description: Anti-Static Spacer /Infant Mask FDA UDI

Identifiers

Primary DI / UDI-DI: 10889483097038 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Atomizer, non-ventilatory 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Atomizer, non-ventilatory

Ventlab by Ventlab Corp. — 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: Ventlab Corp.

Sources (1)

FDA UDI 2456ec30-d79c-4c88-981f-e92e8f892c60 35 fields · synced May 30, 2026