FDA.reportPublic FDA data

3100 HFOV

Primary DI
20846446003403
Brand
3100 HFOV
Company
Carefusion Corporation
Model
766897
Catalog number
766897
Device description
BELLOWS/WATER TRAP BOX4
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSZVentilator, High Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSZVentilator, High FrequencyUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20846446003403PrimaryGS10
00846446003409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084644600340320846446003403
00846446003409008464460034098464460034090846446003409

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

Contacts#

Phone, Email table
PhoneEmail
1-800-231-2466support.smcvent.us@carefusion.
1-800-231-2466support.smcvent.us@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
4
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403296864enFlow980304VS30980304VS302016-09-21
10846446001693Vela11571115712017-06-23
10885403272424AirLife6098ADPG6098ADPG2016-09-01
10885403272431AirLife6098DPG6098DPG2016-09-01
10885403001024AirLife5007P5007P2016-09-01
10885403006425AirLife0020020020022016-09-01
10885403006524AirLife0024300024302016-09-01
10885403006531AirLife0024310024312016-09-01
10885403006548AirLife0024330024332016-09-01
10885403006555AirLife0024340024342016-09-01
10885403006562AirLife0024350024352016-09-01
10885403006579AirLife0024380024382016-09-21
10885403006586AirLife0024430024432016-09-01
10885403006593AirLife0024440024442016-09-01
10885403010958AirLife0024460024462016-09-01
10885403010996AirLife0025010025012016-09-01
10885403011726AirLife0016180016182016-09-01
10885403026980AirLife6200-5046200-5042016-09-01
10885403027079AirLife6934-5046934-5042016-09-01
10885403039072AirLife0021730021732016-09-01

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