Onpro kit

GUDID 10355513192016

On-Body Injector for Neulasta

AMGEN INC.

Autoinjector needle

• Primary Device ID: 10355513192016
• NIH Device Record Key: 7e565691-733c-4525-a18a-15c78004c0a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onpro kit
• Version Model Number: 9002136
• Company DUNS: 039976196
• Company Name: AMGEN INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 0.6 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake

Device Identifiers

Device Issuing Agency	Device ID
GS1	00355513192019 [Primary]
GS1	10355513192016 [Package]; Contains: 00355513192019; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-02
• Device Publish Date: 2019-09-24

Devices Manufactured by AMGEN INC.

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• 10355513192016 - Onpro kit: 2019-10-02On-Body Injector for Neulasta
• 10355513192016 - Onpro kit: 2019-10-02 On-Body Injector for Neulasta
• 10355513770016 - Repatha Pushtronex System: 2019-10-02 On-Body Infusor and Prefilled Cartridge