Surecan™ Safety II Port Access Needle set with Caresite® Y injection site 20G x 0.5in. (12mm)
SURECAN SAFETY II - 4447058-02
Device Description
A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PTI
Device Name: Non-Coring (Huber) Needle
Device Class: 2
Physical State: Sterile medical grade stainless steel hollow needle which may be straight or bent at a 90 degrees, with a hub that is only compatible with other luer type devices. The needle tip angles so the bevel opening provides a clean entry into the port’s septra without damage. The hub may include; an anti-stick safety feature, integrated extension set, or luer activated valve.
Definition: The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A sterile non-coring (Huber) needle used under sterile conditions to pierce the skin above a subcutaneous implanted intravascular infusion port. Once the port is accessed, the needle is pushed through the septum into the port reservoir body that has an integrated catheter.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Various subcutaneous locations; upper arms, chest and abdomen. Indirectly effects the central venous vascular system by facilitating the delivery of intravenous fluids, medications, contrast media and the withdrawal of blood for laboratory sampling.
Regulation Number: 880.5570
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 04046964999925
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04046964858932
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 04046964858932
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 04046964858925
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A