Platypus® AV Fistula Needle Guard

Basic Information

• Brand Name: Platypus® AV Fistula Needle Guard
• Primary DI: 19555240400168
• Version / Model: A100360
• Catalog Number: A100360
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Labeler DUNS: 597723837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1200
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 1
• Public Version Date: 2019-04-08
• Public Version Status: New
• Public Device Record Key: 7ed86615-92d4-4db8-8ab7-8c92ad4ad2b7

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17812	Needle guard	A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	19555240400168	GS1
Unit of Use	09555240400161	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991404	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Direct Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry