AccessGUDID - DEVICE: Skyrizi (48054083023968)

GUDID

Device Identifier (DI) Information

Brand Name: Skyrizi
Version or Model: 19558594
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19558594
Company Name: ABBVIE INC.

Primary DI Number: 48054083023968
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078458370 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QLF	On-Body Injector

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Width: 41 Millimeter
Length: 85 Millimeter
Height: 22.5 Millimeter

Device Record Status

Public Device Record Key: 819d364d-0755-49be-a33e-186b0469ba3a
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022