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Continuous Ventilator

FDA UDI

Class II (US FDA UDI)

by Flight Medical Innovations Ltd

Identity

Trade Name
Continuous Ventilator FDA UDI
Generic Name
Transport electric ventilator FDA UDI
Device Name
F60 DL Eng-Pad FDA UDI
Model / Reference
V61-1010 FDA UDI
Description
F60 DL Eng-Pad FDA UDI

Identifiers

Primary DI / UDI-DI
17290013641073 FDA UDI
510(k) Number
K130171 FDA UDI
FDA Product Code
CBK FDA UDI
GMDN Term
Transport electric 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

No

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: Transport electric ventilatorAnaesthesia ventilator

Continuous Ventilator by Flight Medical Innovations Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia ventilator.

Cleared under the same submission

K130171 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flight Medical Innovations Ltd

Sources (1)

  • FDA UDI 95a923d8-68fd-4b57-9a26-a54d8afbfde3 34 fields · synced Jun 8, 2026