KBMED

GUDID 00850016172044

Enteral Feeding Syringe 10ml blister packing

KB Medical (group), Inc.

Oral/enteral syringe, single-use

• Primary Device ID: 00850016172044
• NIH Device Record Key: aef2e41f-51d3-4f59-8c8c-410ac6a40f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KBMED
• Version Model Number: ES10
• Company DUNS: 105002071
• Company Name: KB Medical (group), Inc.
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850016172044 [Unit of Use]
GS1	00850016172143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182649

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

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: 2021-01-11
• Device Publish Date: 2021-01-01

On-Brand Devices [KBMED]

• 00850016172402: IRRIGATION SYRINGE 60ML,CATHETER TIP, FLAT TOP PISTON, LATEX FREE
• 00850016172372: TRANSFER CONNECTOR FROM ENFIT TO LEGACY CONNECTORS
• 00850016172341: TRANSFER CONNECTOR FROM LEGACY CONNECTORS TO ENFIT
• 00850016172310: Oral Syringe TIP CAPS BLUE BULK
• 00850016172280: ORAL DISPENSER 10ML WITHOUT CAP, BULK
• 00850016172266: ORAL DISPENSER 5ML WITHOUT CAP, BULK
• 00850016172242: ORAL DISPENSER 3ML WITHOUT CAP, BULK
• 00850016172228: ENFIT SYRINGE TIP CAP Blister Packing
• 00850016172198: ORAL DISPENSER 1ML WITHOUT CAP, BULK
• 00850016172181: Enteral Feeding Syringe 100ml blister packing
• 00850016172075: Enteral Feeding Syringe 60ml blister packing
• 00850016172068: Enteral Feeding Syringe 20ml blister packing
• 00850016172044: Enteral Feeding Syringe 10ml blister packing
• 00850016172020: Enteral Feeding Syringe 2.5ml blister packing
• 00850016172112: Enteral Feeding Syringe 1ml blister packing Case of 100
• 00850016172099: Enteral Feeding Syringe 1ml blister packing