FDA.reportPublic FDA data

3100A/B

Primary DI
10846446005868
Brand
3100A/B
Company
Carefusion Corporation
Model
22348-801
Catalog number
22348-801
Device description
3100B Ventilator 3rd Edition
Published
2017-05-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
P890057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890057000MODEL 3100 FREQUENCY OSCILLATORY VENTILATORZOLL Medical Corporation1991-03-29LSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846446005868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084644600586810846446005868

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
800.231.2466support.smcvent.us@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
Serial number
true
No natural rubber latex
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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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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501907521551293100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
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501907521589843100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
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501907521597453100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
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501907521552593100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552663100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
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501907521554713100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554953100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521575673100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05