FlowArt®

GUDID 28699443585395

Extension Set

ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI

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• Primary Device ID: 28699443585395
• NIH Device Record Key: a08ab981-1dc5-4e07-bb05-79c5a59f2685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowArt®
• Version Model Number: UU1010L18
• Company DUNS: 365581688
• Company Name: ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com
• Phone: +1(314) 961-5786
• Email: cs@progressivemedinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08699443585391 [Primary]
GS1	28699443585395 [Package]; Contains: 08699443585391; Package: Box [50 Units]; In Commercial Distribution
GS1	48699443585399 [Package]; Package: Parcel [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190806

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [FlowArt®]

• 28699443585418: Extension Set
• 28699443585401: Extension Set
• 28699443585395: Extension Set
• 28699443585388: Triple Lumen Extension Set
• 28699443585371: Double Lumen Extension Set
• 28699443584213: Needle-Free Split Septum Valve with Three-Way Stopcock
• 28699443583513: Single Set with 1.2 micron Filter Set
• 28699443583490: Single Set with 0.2 micron Filter Set
• 28699443580352: Needle-free Split-Septum Valve, Photoprotective
• 28699443580017: Needle-free Split-Septum Valve
• 28699443585074: Six Port Flexible Manifold w/Split Septum Needle-Free Valves and Integrated Back Check Valves
• 28699443585067: Three Port Flexible Manifold w/Split Septum Needle-Free Valves and Integrated Back Check Valves
• 28699443580055: Needle-Free Split Septum Valve, Double, Hemodialysis
• 28699443580048: Needle-Free Split Septum Valve, Single, Hemodialysis
• 28699443580109: Six Port Flexible Manifold w/One-way Split Septum Needle-Free Valves
• 08699443580075: Three Port Flexible Manifold w/One-way Split Septum Needle-Free Valves