Monoject 712ABE

GUDID 10885380185366

Amber ENFit 12ml Syringe Non-Sterile

Cardinal Health 200, LLC

ENFit oral/enteral syringe, single-use

• Primary Device ID: 10885380185366
• NIH Device Record Key: 2bb18614-d1b9-48a4-9b2d-4b6d8a341409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monoject
• Version Model Number: 712ABE
• Catalog Number: 712ABE
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, LLC
• Device Count: 1000
• 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: true
• 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	10885380185366 [Unit of Use]
GS1	50885380185364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190502

FDA Product Code

• PNR: Enteral Syringes with enteral specific connectors

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: 2023-06-21
• Device Publish Date: 2023-06-13

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