Repatha Pushtronex System

GUDID 10372511770015

On-Body Infusor and Prefilled Cartridge

AMGEN INC.

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