SaveFine ® Insulin Pen Needle - Theproducts have two types, common type and - Promisemed Hangzhou Meditech Co., Ltd.

Duns Number:421335278

Device Description: Theproducts have two types, common type and safety type. Both of the two types are sterile (View more) Theproducts have two types, common type and safety type. Both of the two types are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral models. Different models are distinguished by needle gauge and length.The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube,needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and thesilicone oil is used to needle tube lubrication.The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needlehub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle huband the silicone oil is used to needle tube lubrication.The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needleis designed to reduce occurrence of accidental needle sticks from patient end of the needle byproviding a shield that covers and locks the needle after use. As the user proceeds with inserting theneedle into the skin the shield will retract. After the injection is completed and needle is removedfrom the skin, the shield will automatically extend to cover the needle and lock in place. Once theSafety Type Insulin Pen Needle is in the locked mode, it can no longer be used.Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1. (View less)