FDA UDI
In Commercial Distribution
🇺🇸 United States
Skyrizi
DI: 48054083023968
·
Model: 19558594
·
ABBVIE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Skyrizi
- Primary DI
- 48054083023968
- Version / Model
- 19558594
- Catalog Number
- 19558594
- Company Name
- ABBVIE INC.
- Labeler DUNS
- 078458370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 819d364d-0755-49be-a33e-186b0469ba3a
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QLF | On-Body Injector | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47801 | Subcutaneous self-injection aid | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 48054083023968 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 41 | Millimeter | |
| Length | 85 | Millimeter | |
| Height | 22.5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cartons until time of use. Storage Relative Humidity 15-90%, non-condensing and storage pressure 61.7-106kPa