Hybernite

GUDID 15404013000095

Plastiflex Group NV

Ventilator breathing circuit, reusable

• Primary Device ID: 15404013000095
• NIH Device Record Key: 9b66f4b1-f14e-44b8-a7e9-f67a057f99e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybernite
• Version Model Number: Hybernite ROC US
• 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: true
• Device Combination Product: false
• Single Use: false
• 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	05404013000098 [Primary]
GS1	15404013000095 [Package]; Contains: 05404013000098; Package: [10 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: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-15

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• 15404013000156: HBT IntelliPAP
• 15404013000101: Comfortline 3B
• 15404013000095: Hybernite ROC US
• 15404013000019: Hybernite HBT US
• 05404013004577: Hybernite ROC US
• 05404013004560: ComfortLine Heated Tubing
• 05404013004553: Replacement Comfortline Heated Tubing
• 05404013000807: Hybernite HBT White