Assure® ID Safety Pen Needle

GUDID 36971227400384

The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Diffe

Promisemed Hangzhou Meditech Co., Ltd.

Autoinjector needle Autoinjector needle

• Primary Device ID: 36971227400384
• NIH Device Record Key: 615bc560-4f51-4e94-af91-dbddb539fba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® ID Safety Pen Needle
• Version Model Number: SPN-30-5
• 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	16971227400380 [Unit of Use]
GS1	36971227400384 [Primary]
GS1	56971227400388 [Package]; Package: carton [12 Units]; In Commercial Distribution

Sterilization

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

[36971227400384]

Radiation Sterilization

[36971227400384]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-12

On-Brand Devices [Assure® ID Safety Pen Needle]

• 56971227400395: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 36971227400384: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 56971227400371: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl