FDA.reportPublic FDA data

Classic RT

Primary DI
05404013001613
Brand
Classic RT
Company
Plastiflex Group NV
Model
Ultralite Mini 15 x 300 White
Published
2019-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15404013001610PackageGS1240In Commercial Distribution
25404013001617PackageGS120In Commercial Distribution
05404013001613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1540401300161015404013001610
2540401300161725404013001617
05404013001613054040130016135404013001613

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 artificial airway/respiratory mask (not included). 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 a carbon dioxide cuvette and/or 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.

Regulatory Flags#

DUNS number
371165452
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404013000227Hybernite RTHybernite RT 12 ex2016-09-15
05404013000234Hybernite RTHybernite RT 12 ins+Inc2017-07-19
05404013000241Hybernite RT Hybernite RT 15 ins2016-09-15
05404013000258Hybernite RTHybernite RT 15 ex2016-09-15
05404013000265Hybernite RTHybernite RT 19 ins2016-09-15
05404013000272Hybernite RTHybernite RT 19 ex2016-09-15
05404013000999Classic RTClassic RT 12x500 Blue2017-07-19
05404013001002Classic RTClassic RT 12x900 Blue2017-07-19
05404013001583Classic RTUltralite Mini 15 x 300 Blue2019-03-05
05404013001606Classic RTUltralite Mini 15 x 300 White2019-03-05
05404013001620Classic RTUltralite Mini 15 x 400 Blue2019-03-05
05404013001637Classic RTUltralite Mini 15 x 400 White2019-03-05
05404013001644Classic RTUltralite Mini 15 x 400 White2019-03-05
05404013001651Classic RTUltralite Mini 15 x 450 Blue2019-03-05
05404013001668Classic RTUltralite Mini 15 x 450 White2019-03-05
05404013001675Classic RTUltralite Mini 15 x 450 White2019-03-05
05404013001682Classic RTUltralite Mini 15 x 500 Blue2019-03-05
05404013001699Classic RTUltralite Mini 15 x 500 White2019-03-06
05404013001705Classic RTUltralite Mini 15 x 600 White2019-03-05
05404013001712Classic RTUltralite Mini 15 x 600 White2019-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
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10889483570517AirLife™AIRLIFEBZO2025-03-06
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