Plastiflex Group NV

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (BZE) (10)

Premarket Exempt

No Yes

Clear

Hybernite - 05404013000012 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite - 05404013000098 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite - 05404013000104 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite - 05404013000159 Catalog Number :

Device Class :

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite - 05404013000173 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite - 05404013000180 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite RT - 05404013000210 Catalog Number :

Device Class :

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite RT - 05404013000227 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite RT - 05404013000234 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Hybernite RT - 05404013000241 Catalog Number :

Device Class : 2

Duns Number: 371165452

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

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