Bunnell

Primary DI
00616120000020
Brand
Bunnell
Company
BUNNELL, INCORPORATED
Model
902
Device description
LifePulse High Frequency Ventilator - Patient Circuit with LifePort Adapters Kit
Published
2015-07-28
Public version status
Update
Distribution status
Not 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
P850064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P850064000MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATORBunnell, Inc.1988-06-30LSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10616120000027PackageGS12In Commercial Distribution
00616120000020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061612000002710616120000027
00616120000020006161200000206161200000200616120000020

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].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023869365
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10616120000034LifePort2.5 mm90252014-09-24
10616120000041LifePort3.5 mm90352014-09-24
10616120000058LifePort4.5 mm90452014-09-24
10616120000065LifePort5.5 mm90552014-09-24
10616120000072LifePort3.0 mm90302016-12-29
00616120000006LifePulse203A2014-09-24
00616120000013LifePulse3122014-09-24
00616120000105LifePulse2042017-09-14
00616120000112LifePulse3142017-09-14
00616120000082Bunnell9032017-03-30
10616120000089Bunnell9032017-03-30

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Primary DI, Brand, Company table
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