FDA.reportPublic FDA data

Hybernite RT

Primary DI
15404013000231
Brand
Hybernite RT
Company
Plastiflex Group NV
Model
Hybernite RT 12 ins+Inc
Published
2017-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
15404013000231PackageGS160In Commercial Distribution
05404013000234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1540401300023115404013000231
05404013000234054040130002345404013000234

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

Regulatory Flags#

DUNS number
371165452
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
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