Verifine ® Common Type Insulin Pen Needle

GUDID 36971227400049

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-pyroge

Promisemed Hangzhou Meditech Co., Ltd.

Autoinjector needle

• Primary Device ID: 36971227400049
• NIH Device Record Key: d0858b07-1fd3-4cdd-9588-61301337c397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verifine ® Common Type Insulin Pen Needle
• Version Model Number: IPN-31-6
• Company DUNS: 421335278
• Company Name: Promisemed Hangzhou Meditech Co., Ltd.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	16971227400045 [Unit of Use]
GS1	36971227400049 [Primary]
GS1	56971227400043 [Package]; Package: carton [50 Units]; In Commercial Distribution

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[36971227400049]

Ethylene Oxide

[36971227400049]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-25

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