Classic

GUDID 15404013002228

Plastiflex Group NV

Ventilator breathing circuit, reusable

• Primary Device ID: 15404013002228
• NIH Device Record Key: a834dc6d-5bc1-498c-8648-be0e7bbe40cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Classic
• Version Model Number: Classic 19 Black 1830
• Company DUNS: 371165452
• Company Name: Plastiflex Group NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404013002221 [Primary]
GS1	15404013002228 [Package]; Contains: 05404013002221; Package: [45 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: 2019-12-11
• Device Publish Date: 2019-03-03

On-Brand Devices [Classic]

• 15404013002228: Classic 19 Black 1830
• 15404013001481: Classic 19 US