SaveFine ® Insulin Pen Needle

GUDID 36971227400674

The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several 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 the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety 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, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.

Promisemed Hangzhou Meditech Co., Ltd.

Autoinjector needle
Primary Device ID36971227400674
NIH Device Record Keya118ce5b-8905-486d-906b-837c633216aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaveFine ® Insulin Pen Needle
Version Model NumberIPN-29-12
Company DUNS421335278
Company NamePromisemed Hangzhou Meditech Co., Ltd.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS116971227400670 [Unit of Use]
GS136971227400674 [Primary]

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[36971227400674]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [SaveFine ® Insulin Pen Needle]

36971227400766The products have two types, common type and safety type. Both of the two types are sterile with
36971227400759The products have two types, common type and safety type. Both of the two types are sterile with
36971227400742The products have two types, common type and safety type. Both of the two types are sterile with
36971227400728The products have two types, common type and safety type. Both of the two types are sterile with
36971227400704The products have two types, common type and safety type. Both of the two types are sterile with
36971227400698The products have two types, common type and safety type. Both of the two types are sterile with
36971227400681The products have two types, common type and safety type. Both of the two types are sterile with
36971227400674The products have two types, common type and safety type. Both of the two types are sterile with

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