FDA.reportPublic FDA data

3100A HFOV

Primary DI
10846446003147
Brand
3100A HFOV
Company
Carefusion Corporation
Model
11518-21VL
Catalog number
11518-21VL
Device description
BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,21VL
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
10846446003147PrimaryGS10
00846446003140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084644600314710846446003147
00846446003140008464460031408464460031400846446003140

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
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201907522010613100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
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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
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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
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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