inpen™

GUDID 00763000645281

COMPANION MEDICAL, INC.

Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical

• Primary Device ID: 00763000645281
• NIH Device Record Key: ba0a3b8c-89d1-49f7-ac82-34a076ee4329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inpen™
• Version Model Number: MMT-105EVNNWW
• Company DUNS: 057594435
• Company Name: COMPANION MEDICAL, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000645281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201337

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-16
• Device Publish Date: 2022-08-08

On-Brand Devices [inpen™]

• 00763000645298: MMT-105EVELWW
• 00763000645281: MMT-105EVNNWW