FDA.reportPublic FDA data

Classic RT

Primary DI
15404013002136
Brand
Classic RT
Company
Plastiflex Group NV
Model
Classic RT 19 x 800 White
Published
2019-03-03
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
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
15404013002136PackageGS190In Commercial Distribution
25404013002133PackageGS115In Commercial Distribution
05404013002139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1540401300213615404013002136
2540401300213325404013002133
05404013002139054040130021395404013002139

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
Primary DIBrandCompanyProduct codePublished
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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
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14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
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