FDA.reportPublic FDA data

LifePort

Primary DI
10616120000065
Brand
LifePort
Company
BUNNELL, INCORPORATED
Model
5.5 mm
Catalog number
9055
Device description
LifePulse High Frequency Ventilator - 5.5 mm LifePort Adapter
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
LSZVentilator, High Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSZVentilator, High FrequencyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P850064011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P850064011MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATORBunnell, Inc.1988-06-30LSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10616120000065PrimaryGS10
00616120000068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061612000006510616120000065
00616120000068006161200000686161200000680616120000068

GMDN Terms#

Term, Definition table
TermDefinition
Stationary electric high-frequency ventilatorA mains electricity (AC-powered) automatic cycling machine intended to assist or control alveolar ventilation using a frequency that is considerably higher than the physiological breathing rate and a tidal volume less than or equal to the anatomic dead space. The device will typically function independently or may be used in conjunction with an intensive care ventilator to superimpose its high frequency percussive ventilation on top of a normal ventilation frequency. It is typically used in critical care situations on patients with respiratory disease requiring ventilatory assistance, typically through an artificial airway [e.g., endotracheal (ET) tube or tracheostomy].

Regulatory Flags#

DUNS number
023869365
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616120000020Bunnell9022015-07-28
10616120000034LifePort2.5 mm90252014-09-24
10616120000041LifePort3.5 mm90352014-09-24
10616120000058LifePort4.5 mm90452014-09-24
10616120000072LifePort3.0 mm90302016-12-29
00616120000006LifePulse203A2014-09-24
00616120000013LifePulse3122014-09-24
00616120000105LifePulse2042017-09-14
00616120000112LifePulse3142017-09-14
00616120000082Bunnell9032017-03-30
10616120000089Bunnell9032017-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
101907521553123100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
201907522010613100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
101907522010193100 HFOVVYAIRE MEDICAL, INC.LSZ2024-11-05
101907522007463100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907522007603100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907522015763100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907521488403100A/B HFOVVYAIRE MEDICAL, INC.LSZ2021-11-08
501907521599123100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-16
501907521551053100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551123100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551293100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551363100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551433100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521554883100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521589843100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521590043100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521597453100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
101907521588013100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
101907521588183100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
101907521588253100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521551503100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552593100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552663100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554263100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554333100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554573100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554643100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554713100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554953100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521575673100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05