Hybernite HRU19018WT0033GI

GUDID 05404013004553

Plastiflex Group NV

Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable Ventilator breathing circuit, reusable

• Primary Device ID: 05404013004553
• NIH Device Record Key: 573acf2f-5a7a-4542-8dcd-5a84a219bfed
• Commercial Distribution Discontinuation: 2028-07-03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybernite
• Version Model Number: Replacement Comfortline Heated Tubing
• Catalog Number: HRU19018WT0033GI
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	05404013004553 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-11
• Device Publish Date: 2022-07-03

On-Brand Devices [Hybernite]

• 15404013000989: Sleepbox Heated Tube
• 15404013000187: Hybernite HBT white US
• 15404013000170: 3BCL 1010 3B ComfortLine
• 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