IMed Products IM68120

GUDID 10810110921228

IMed EVA Gravity Bag, 1000mL, 3-Legs

INTEGRATED MEDICAL SYSTEMS, INC.

Basic intravenous administration set, noninvasive

• Primary Device ID: 10810110921228
• NIH Device Record Key: d2a7a644-4a26-4159-b2e9-a404613ab1bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMed Products
• Version Model Number: IM68120
• Catalog Number: IM68120
• Company DUNS: 962364444
• Company Name: INTEGRATED MEDICAL SYSTEMS, INC.
• Device Count: 50
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810110921221 [Unit of Use]
GS1	10810110921228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030888

FDA Product Code

• KPE: Container, I.V.

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: 2025-04-28
• Device Publish Date: 2025-04-18

On-Brand Devices [IMed Products]

• 10810110920610: IMed Elastomeric Pump - 60mL/5mL per Hour
• 10810110920603: IMed Elastomeric Pump - 125mL/5mL per Hour
• 10810110920597: IMed Elastomeric Pump - 125mL/5mL per Hour
• 10810110920573: IMed Elastomeric Pump - 300mL/6mL per Hour
• 10810110920566: IMed Elastomeric Pump - 270mL/10mL per Hour
• 10810110920559: IMed Elastomeric Pump - 270mL/5mL per Hour
• 10810110920542: IMed Elastomeric Pump - 270mL/2mL per Hour
• 10810110920535: IMed Elastomeric Pump - 100mL/2mL per Hour
• 10810110920528: IMed Elastomeric Pump - 500mL/20mL per Hour
• 10810110920511: IMed Elastomeric Pump - 270mL/5mL per Hour
• 10810110920504: IMed Elastomeric Pump - 270mL/4mL per Hour
• 10810110920498: IMed Elastomeric Pump - 270mL/2mL per Hour
• 10810110920481: IMed Elastomeric Pump - 270mL/1mL per Hour
• 60810110920486: IMed Elastomeric Pump - 270mL/10mL per Hour, Individual & 6-Pack
• 10810110920467: IMed Elastomeric Pump - 100mL/5mL per Hour
• 10810110920450: IMed Elastomeric Pump - 100mL/2mL per Hour
• 10810110920443: IMed Elastomeric Pump - 270mL/175mL per Hour
• 10810110920436: IMed Elastomeric Pump - 250mL/50mL per Hour
• 10810110920429: IMed Elastomeric Pump - 250mL/500mL per Hour
• 10810110920412: IMed Elastomeric Pump - 250mL/125mL per Hour
• 10810110920405: IMed Elastomeric Pump - 250mL/100mL per Hour
• 10810110920399: IMed Elastomeric Pump - 200mL/200mL per Hour
• 10810110920382: EZ-FLOW Elastomeric Pump - 200mL/100mL per Hour
• 10810110920375: EZ-FLOW Elastomeric Pump - 500mL/250mL per Hour
• 10810110920368: IMed Elastomeric Pump - 400mL/200mL per Hour
• 10810110920351: IMed Elastomeric Pump - 400mL/100mL per Hour
• 10810110920344: IMed Elastomeric Pump - 250mL/250mL per Hour
• 10810110920337: IMed Elastomeric Pump - 250mL/175mL per Hour
• 60810110920325: IMed Elastomeric Pump - 100mL/200mL per Hour, Individual & 6-Packs
• 60810110920318: EZ-FLOW Elastomeric Pump, 100mL Vol/100mL Hr, Individual & 6-Pack
• 10810110920306: IMed Elastomeric Pump - 100mL/50mL per Hour
• 10810110920290: IMed Elastomeric Pump - 50mL/50mL per Hour
• 10810110921228: IMed EVA Gravity Bag, 1000mL, 3-Legs