Repatha Pushtronex System

GUDID 10372511770015

On-Body Infusor and Prefilled Cartridge

AMGEN INC.

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle

• Primary Device ID: 10372511770015
• NIH Device Record Key: 881a7ffb-c1d9-43d9-8129-cd9e7f79e97c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Repatha Pushtronex System
• Version Model Number: 9006655
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter
• Total Volume: 3.5 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of the sight and reach of children
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in Carton to Protect from Light
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze or Shake

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372511770018 [Primary]
GS1	10372511770015 [Package]; Contains: 00372511770018; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• FRN: Pump, Infusion

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: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [Repatha Pushtronex System]

• 10355513770016: On-Body Infusor and Prefilled Cartridge
• 10372511770015: On-Body Infusor and Prefilled Cartridge