Hybernite RT

GUDID 15404013000248

Plastiflex Group NV

Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use

• Primary Device ID: 15404013000248
• NIH Device Record Key: 45131cd2-1b94-4240-bcc5-96a5078a7420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybernite RT
• Version Model Number: Hybernite RT 15 ins
• Company DUNS: 371165452
• Company Name: Plastiflex Group NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404013000241 [Primary]
GS1	15404013000248 [Package]; Contains: 05404013000241; Package: [45 Units]; In Commercial Distribution

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-15

On-Brand Devices [Hybernite RT ]

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