Classic RT

GUDID 15404013001603

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: 15404013001603
• NIH Device Record Key: 2ee4f53d-45aa-41c0-89b7-745e2b0093d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Classic RT
• Version Model Number: Ultralite Mini 15 x 300 White
• 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	05404013001606 [Primary]
GS1	15404013001603 [Package]; Contains: 05404013001606; Package: [240 Units]; In Commercial Distribution
GS1	25404013001600 [Package]; Contains: 05404013001606; Package: [20 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: 2019-03-05

On-Brand Devices [Classic RT]

• 15404013002242: Classic RT 19 x 1830 White
• 15404013002204: Classic RT 19 x 1830 Blue
• 15404013002198: Classic RT 19 x 1500 White
• 15404013002181: Classic RT 19 x 1500 Blue
• 15404013002174: Classic RT 19 x 1200 White
• 15404013002167: Classic RT 19 x 1200 Blue
• 15404013002150: Classic RT 19 x 1000 White
• 15404013002143: Classic RT 19 x 1000 Blue
• 15404013002136: Classic RT 19 x 800 White
• 15404013002129: Classic RT 19 x 800 Blue
• 15404013002112: Classic RT 19 x 700 White
• 15404013001719: Ultralite Mini 15 x 600 White
• 15404013001702: Ultralite Mini 15 x 600 White
• 15404013001696: Ultralite Mini 15 x 500 White
• 15404013001689: Ultralite Mini 15 x 500 Blue
• 15404013001672: Ultralite Mini 15 x 450 White
• 15404013001665: Ultralite Mini 15 x 450 White
• 25404013001655: Ultralite Mini 15 x 450 Blue
• 15404013001641: Ultralite Mini 15 x 400 White
• 15404013001634: Ultralite Mini 15 x 400 White
• 15404013001627: Ultralite Mini 15 x 400 Blue
• 15404013001610: Ultralite Mini 15 x 300 White
• 15404013001603: Ultralite Mini 15 x 300 White
• 15404013001580: Ultralite Mini 15 x 300 Blue
• 15404013001009: Classic RT 12x900 Blue
• 15404013000996: Classic RT 12x500 Blue
• 15404013001924: Ultralite Mini 15 x 2000 Blue
• 15404013001917: Ultralite Mini 15 x 1830 White
• 15404013001900: Ultralite Mini 15 x 1830 White
• 15404013001894: Ultralite Mini 15 x 1830 White
• 15404013001870: Ultralite Mini 15 x 1830 Blue
• 25404013001860: Ultralite 15 x 1500 White
• 15404013001856: Ultralite 15 x 1500 White
• 15404013001849: Ultralite 15 x 1500 Blue
• 15404013001832: Ultralite 15 x 1200 White
• 15404013001825: Ultralite 15 x 1200 White
• 15404013001818: Ultralite 15 x 1200 Blue
• 15404013001801: Ultralite 15 x 1000 White
• 15404013001795: Ultralite 15 x 1000 White
• 15404013001788: Ultralite 15 x 1000 Blue
• 15404013001771: Ultralite 15 x 800 White
• 15404013001764: Ultralite Mini 15 x 800 White
• 15404013001757: Ultralite Mini 15 x 800 Blue
• 15404013001740: Ultralite 15 x 700 White
• 15404013001733: Ultralite Mini 15x700 White
• 15404013001726: Ultralite Mini 15x700 blue
• 15404013002105: Classic RT 19 x 700 Blue
• 15404013002099: Classic RT 19 x 600 White
• 15404013002082: Classic RT 19 x 600 Blue
• 15404013002075: Classic RT 19 x 500 White