Platypus® AV Fistula Needle Guard A100360

GUDID 19555240400168

Platypus® is intended for use in the prevention of accidental needle stick injuries upon completion of hemodialysis and apheresis procedures; Platypus® has been designed to allow the winged needle assembly to be pulled into the Platypus® and once fully engaged, the winged needle assembly is locked in, thus shielding and locking the needle and preventing needle exposure; Platypus® is supplied bulk, non-sterile.

ITL ASIA PACIFIC SDN. BHD.

Needle guard

• Primary Device ID: 19555240400168
• NIH Device Record Key: 7ed86615-92d4-4db8-8ab7-8c92ad4ad2b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Platypus® AV Fistula Needle Guard
• Version Model Number: A100360
• Catalog Number: A100360
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Device Count: 1200
• 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

Customer Support Contacts

• Phone: +18884112851
• Email: sales@itlbiomedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555240400161 [Unit of Use]
GS1	19555240400168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991404

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2019-04-08
• Device Publish Date: 2019-03-29

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