Verifine® Safety Type Insulin Pen Needle - The products have two types, common type and - Promisemed Hangzhou Meditech Co., Ltd.

Duns Number:421335278

Device Description: The products have two types, common type and safety type. Both of the two types are steril The products 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.

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More Product Details

Catalog Number

-

Brand Name

Verifine® Safety Type Insulin Pen Needle

Version/Model Number

SPN-29-8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

6dbe2636-0060-48c0-84d2-359c0c43b533

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 25, 2017

Additional Identifiers

Package DI Number

56971227400111

Quantity per Package

12

Contains DI Package

36971227400117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"PROMISEMED HANGZHOU MEDITECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1