FOLLISTIM AQ CARTRIDGE 300IU

GUDID 60378206129019

Organon LLC

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle

• Primary Device ID: 60378206129019
• NIH Device Record Key: 9bcf6457-d135-47fe-bc7d-05ed15438c33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOLLISTIM AQ CARTRIDGE 300IU
• Version Model Number: 1044615
• Company DUNS: 117494753
• Company Name: Organon LLC
• 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: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com
• Phone: +1(844)674-3200
• Email: dpoc.us@organon.com

Device Dimensions

• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00378206129017 [Primary]
GS1	60378206129019 [Package]; Contains: 00378206129017; Package: box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162516

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-09
• Device Publish Date: 2024-01-01

Devices Manufactured by Organon LLC

• 60378206129019 - FOLLISTIM AQ CARTRIDGE 300IU: 2024-01-09
• 60378206129019 - FOLLISTIM AQ CARTRIDGE 300IU: 2024-01-09
• 60378206129590 - FOLLISTIM AQ CARTRIDGE 300IU SAM: 2024-01-09
• 60378206130015 - FOLLISTIM AQ CARTRIDGE 600IU: 2024-01-09
• 60378206130596 - FOLLISTIM AQ CARTRIDGE 600IU SAM: 2024-01-09
• 60378206131012 - FOLLISTIM AQ CARTRIDGE 900IU: 2024-01-09
• 60840164519442 - FOLLISTIM PEN STARTER KIT: 2024-01-09
• 60840164519459 - FOLLISTIM PEN STARTER KIT SAM: 2024-01-09
• 60840164521131 - JADA System: 2023-02-23 Vacuum-induced Hemorrhage Control System