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LifePulse

FDA UDI

Class III (US FDA UDI)

by Bunnell, Incorporated

Identity

Trade Name
LifePulse FDA UDI
Generic Name
Stationary electric high-frequency ventilator FDA UDI
Device Name
LifePulse High Frequency Ventilator - Patient Box Model 314 FDA UDI
Model / Reference
314 FDA UDI
Description
LifePulse High Frequency Ventilator - Patient Box Model 314 FDA UDI

Identifiers

Primary DI / UDI-DI
00616120000112 FDA UDI
PMA Number
P850064 FDA UDI
FDA Product Code
LSZ FDA UDI
GMDN Term
Stationary electric high-frequency ventilator FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Stationary electric high-frequency ventilator

LifePulse by Bunnell, Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary electric high-frequency ventilator.

Cleared under the same submission

P850064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bunnell, Incorporated

Sources (1)

  • FDA UDI ca290875-a146-4ee1-9d47-2db680508894 34 fields · synced Jun 1, 2026