FDA.reportPublic FDA data

Hybernite

Primary DI
05404013000104
Brand
Hybernite
Company
Plastiflex Group NV
Model
Comfortline 3B
Published
2016-09-15
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
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
15404013000101PackageGS110In Commercial Distribution
05404013000104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1540401300010115404013000101
05404013000104054040130001045404013000104

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, reusableAn 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, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, 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. This is a reusable device.

Regulatory Flags#

DUNS number
371165452
Device count
1
Kit
true
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 exHPN12016WT0FQWBB2016-09-15
05404013000234Hybernite RTHybernite RT 12 ins+IncHPN12020BT1FQWBB2017-07-19
05404013000241Hybernite RTHybernite RT 15 insHPN15017BT1FTWBB2016-09-15
05404013000258Hybernite RTHybernite RT 15 exHPN15017WT0FRWBB2016-09-15
05404013000265Hybernite RTHybernite RT 19 insHPN19016BT1FTWBB2016-09-15
05404013000272Hybernite RTHybernite RT 19 exHPN19016WT0FSWBB2016-09-15
05404013003730Hybernite RTRT 114HFN19022BT1STWGL2020-08-09
05404013004560HyberniteComfortLine Heated TubingHHU19018WT0033CK2022-07-03
05404013000210Hybernite RTHybernite RT 12 insHPN12016BT1FTWBB2016-09-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344039418HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043064HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043071HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043101HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043118HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344176434HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176441HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176458HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176465HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344011629HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-01-21
10889483617007AirLife™AIRLIFEBZE2025-02-27
09420012448422Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012453204Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012459213Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
10197344043040HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043057HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043088HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043095HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
00848530104153Passive Heated Breathing Circuit KitSunset Healthcare Solutions, Inc.BZE2024-05-30
00848530070670Heated CPAP Tube for DreamStation Series and PR System OneSunset Healthcare Solutions, Inc.BZE2024-03-05
00848530102753Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.BZE2024-02-20
04048675389583VentStar humidifier chamber (N)Drägerwerk AG & Co. KGaABZE2023-07-21
04048675411758VentStar Helix heated (N) PlusDrägerwerk AG & Co. KGaABZE2023-07-21
04048675414520Double connector 11ID/15OD 20xDrägerwerk AG & Co. KGaABZE2023-07-21
04048675742739VentStar Helix dual heated N Exten. KitDrägerwerk AG & Co. KGaABZE2023-07-21
09420012431080Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012431165Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012432162Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012456601Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
05404013004560HybernitePlastiflex Group NVBZE2022-07-03