FDA.reportPublic FDA data

Hybernite RT

Primary DI
05404013000258
Brand
Hybernite RT
Company
Plastiflex Group NV
Model
Hybernite RT 15 ex
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15404013000255PackageGS145In Commercial Distribution
05404013000258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1540401300025515404013000255
05404013000258054040130002585404013000258

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
Lot or batch
true
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
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
05404013001613Classic 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

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Primary DI, Brand, Company table
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