Skyrizi

Primary DI
48054083023968
Brand
Skyrizi
Company
ABBVIE INC.
Model
19558594
Catalog number
19558594
Device description
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.
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QLFOn-Body Injector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLFOn-Body InjectorGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
48054083023968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4805408302396848054083023968

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous self-injection aidA device designed to be used by a layperson to self-administer a subcutaneous injection, typically by a person who has difficulty with painless self-injections [e.g., patients with rheumatoid arthritis (RA)]. It is typically in the form of a tube or container in which a prefilled syringe assembly (syringe with medication and needle) is placed and secured; the user grips the device, places it on the body surface at the injection site, and presses the plunger of the syringe to inject the medication. The device may also enable needle penetration at an appropriate angle (typically 90° to the body surface) and to a pre-set depth. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height22.5Millimeter
Length85Millimeter
Width41Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cartons until time of use. Storage Relative Humidity 15-90%, non-condensing and storage pressure 61.7-106kPa
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
078458370
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054083007953AbbVie Hip Pack106372021-10-18
08054083007960AbbVie Cross Body Pack106362021-10-18
08054083008103AbbVie Chest Pack106352021-10-18
08054083008110AbbVie Snug Vest XS106332021-10-18
08054083008127AbbVie Snug Vest S106332021-10-18
08054083008134AbbVie Snug Vest M106332021-10-18
08054083008141AbbVie Snug Vest L106332021-10-18
08054083008165AbbVie Snug Vest XXL106332021-10-18
08054083008172AbbVie Lightweight Vest XS106342021-10-19
08054083008189AbbVie Lightweight Vest S106342021-10-19
08054083008196AbbVie Lightweight Vest M106342021-10-19
08054083008202AbbVie Lightweight Vest L106342021-10-19
08054083008219AbbVie Lightweight Vest XL106342021-10-19
08054083008226AbbVie Lightweight Vest XXL106342021-10-19
08054083022413Abbvie Fitted Vest XXXS0AV5512021-09-20
08054083022420Abbvie Fitted Vest XXS0AV5512021-09-17
08054083022444Abbvie Fitted Vest Small0AV5512021-09-17
08054083022451Abbvie Fitted Vest Medium0AV5512021-09-14
08054083022468Abbvie Fitted Vest Large0AV5512021-09-14
08054083022475Abbvie Fitted Vest XL0AV5512021-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851869007019EMPAVELI® InjectorEnable Injections, Inc.QLF2023-10-30
10851869007016EMPAVELI® InjectorEnable Injections, Inc.QLF2023-10-30
48054083023234SkyriziABBVIE INC.QLF2022-07-07