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Penlon

FDA UDI

Class II (US FDA UDI)

by Penlon , Ltd.

Identity

Trade Name
Penlon FDA UDI
Generic Name
Anaesthesia ventilator FDA UDI
Model / Reference
AV-S Remote FDA UDI

Identifiers

Primary DI / UDI-DI
05051977000055 FDA UDI
510(k) Number
K051222 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Anaesthesia ventilator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5895 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

Category: Anaesthesia ventilator

Penlon by Penlon , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia ventilator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Penlon , Ltd.

Sources (1)

  • FDA UDI 80de942c-4999-4346-8aa7-df6b7c049874 34 fields · synced May 30, 2026