Clasic Rt

GUDID 15404013002068

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: 15404013002068
• NIH Device Record Key: d734efd4-b3be-47be-8050-bd0127ff39c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clasic Rt
• Version Model Number: Classic RT 19 x 500 Blue
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404013002061 [Primary]
GS1	15404013002068 [Package]; Contains: 05404013002061; Package: [135 Units]; In Commercial Distribution
GS1	25404013002065 [Package]; Contains: 05404013002061; Package: [15 Units]; In Commercial Distribution

FDA Product Code

• BZO: Set, Tubing And Support, Ventilator (W Harness)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-03-28

Devices Manufactured by Plastiflex Group NV

• 05404013000807 - Hybernite: 2022-07-11
• 05404013004553 - Hybernite: 2022-07-11
• 05404013004560 - Hybernite: 2022-07-11
• 05404013004577 - Hybernite: 2022-07-11
• 05404013003693 - Hybernite RT: 2020-08-17 Hybernite RT 114 Convenience kit
• 15404013003737 - Hybernite RT: 2020-08-17 Hybernite RT 114
• 15404013000019 - Hybernite: 2019-12-11
• 15404013000095 - Hybernite: 2019-12-11