Skyrizi 19558594

GUDID 48054083023968

The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 180mg/1.2mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.

ABBVIE INC.

Subcutaneous self-injection aid

• Primary Device ID: 48054083023968
• NIH Device Record Key: 819d364d-0755-49be-a33e-186b0469ba3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skyrizi
• Version Model Number: 19558594
• Catalog Number: 19558594
• Company DUNS: 078458370
• Company Name: ABBVIE 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 41 Millimeter
• Length: 85 Millimeter
• Height: 22.5 Millimeter
• Width: 41 Millimeter
• Length: 85 Millimeter
• Height: 22.5 Millimeter
• Width: 41 Millimeter
• Length: 85 Millimeter
• Height: 22.5 Millimeter
• Width: 41 Millimeter
• Length: 85 Millimeter
• Height: 22.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cartons until time of use. Storage Relative Humidity 15-90%, non-condensing and storage pressure 61.7-106kPa
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cartons until time of use. Storage Relative Humidity 15-90%, non-condensing and storage pressure 61.7-106kPa
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cartons until time of use. Storage Relative Humidity 15-90%, non-condensing and storage pressure 61.7-106kPa
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cartons until time of use. Storage Relative Humidity 15-90%, non-condensing and storage pressure 61.7-106kPa

Device Identifiers

Device Issuing Agency	Device ID
GS1	48054083023968 [Primary]

FDA Product Code

• QLF: On-Body Injector

Sterilization

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

[48054083023968]

Ethylene Oxide

[48054083023968]

Ethylene Oxide

[48054083023968]

Ethylene Oxide

[48054083023968]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Skyrizi]

• 48054083023234: The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartr
• 48054083023968: The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartr