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Vocsn

FDA UDI

Class II (US FDA UDI)

by Ventec Life Systems, Inc.

Identity

Trade Name
VOCSN FDA UDI
Generic Name
Portable electric ventilator FDA UDI
Model / Reference
V*Home, English FDA UDI

Identifiers

Catalog Number
PRT-01444-000 FDA UDI
Primary DI / UDI-DI
00855573007822 FDA UDI
510(k) Number
K162877 FDA UDI
FDA Product Code
BZE FDA UDI
NOU FDA UDI
CAH FDA UDI
CBK FDA UDI
GMDN Term
Portable electric ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5270 FDA UDI
868.5895 FDA UDI
868.5260 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Portable electric ventilator

Vocsn by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable electric ventilator.

Cleared under the same submission

K162877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ventec Life Systems, Inc.

Sources (1)

  • FDA UDI 997ad27b-7c68-44ef-aa50-de6353caf475 35 fields · synced May 29, 2026