Rebiject II

GUDID 04054839025808

Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-filled glass syringes.

EMD SERONO, INC.

Syringe-loaded injector, manual, home-use Syringe-loaded medication/vaccine injector, manual, home-use Syringe-loaded medication/vaccine injector, manual, home-use Syringe-loaded medication/vaccine injector, manual, home-use Syringe-loaded medication/vaccine injector, manual, home-use Syringe-loaded medication/vaccine injector, manual, home-use Syringe-loaded medication/vaccine injector, manual, home-use

• Primary Device ID: 04054839025808
• NIH Device Record Key: 4239b595-3712-4ca5-a1cf-92a75d744801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rebiject II
• Version Model Number: U6722302
• Company DUNS: 088514898
• Company Name: EMD SERONO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-447-3243
• Email: xx@xx.xx
• Phone: 1-877-447-3243
• Email: xx@xx.xx
• Phone: 1-877-447-3243
• Email: xx@xx.xx
• Phone: 1-877-447-3243
• Email: xx@xx.xx
• Phone: 1-877-447-3243
• Email: xx@xx.xx
• Phone: 1-877-447-3243
• Email: xx@xx.xx
• Phone: 1-877-447-3243
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04054839025808 [Primary]

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-26

Devices Manufactured by EMD SERONO, INC.

• 04046963412791 - one.click needle: 2023-10-03 Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04046963413880 - Serofine needles 29 G: 2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04046963414047 - Serofine needles 30G: 2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
• 04054839025792 - one.click: 2019-04-19 one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in c
• 04054839025860 - easypod: 2019-04-19 easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]
• 04054839025808 - Rebiject II: 2018-03-29Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-filled glass syringes.
• 04054839025808 - Rebiject II: 2018-03-29 Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-fil
• 04054839025914 - Clip-on Spacers for Rebif: 2018-03-29 Titration Clip for Dose Titration using Rebif® 22 mcg or 44 mcg Pre-filled Syringe.