Hybernite RT

GUDID 15404013000262

Plastiflex Group NV

Ventilator breathing circuit, single-use
Primary Device ID15404013000262
NIH Device Record Keyc4ad61b1-046e-4322-b572-535bd1eb1b23
Commercial Distribution StatusIn Commercial Distribution
Brand NameHybernite RT
Version Model NumberHybernite RT 19 ins
Company DUNS371165452
Company NamePlastiflex Group NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105404013000265 [Primary]
GS115404013000262 [Package]
Contains: 05404013000265
Package: [40 Units]
In Commercial Distribution

FDA Product Code

BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-27
Device Publish Date2016-09-15

On-Brand Devices [Hybernite RT]

15404013000279Hybernite RT 19 ex
15404013000262Hybernite RT 19 ins
15404013000255Hybernite RT 15 ex
15404013000248Hybernite RT 15 ins
15404013000231Hybernite RT 12 ins+Inc
15404013000224Hybernite RT 12 ex
05404013000210Hybernite RT 12 ins
15404013003737Hybernite RT 114
05404013003693Hybernite RT 114 Convenience kit

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