MediBag 220278

GUDID 20857595005125

MediBag - 420 mL

SUMMIT MEDICAL PRODUCTS, INC.

Parenteral/enteral solution bag

• Primary Device ID: 20857595005125
• NIH Device Record Key: f294b6e9-ca72-4e16-8ad2-62cde33198d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediBag
• Version Model Number: 220278
• Catalog Number: 220278
• Company DUNS: 831704841
• Company Name: SUMMIT MEDICAL PRODUCTS, 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: 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

Customer Support Contacts

• Phone: (801)352-1888
• Email: service@ambitpump.com

Device Dimensions

• Total Volume: 420 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857595005121 [Primary]
GS1	10857595005128 [Package]; Contains: 00857595005121; Package: [30 Units]; In Commercial Distribution
GS1	20857595005125 [Package]; Contains: 10857595005128; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001287

FDA Product Code

• KPE: Container, I.V.

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-09

On-Brand Devices [MediBag]

• 20857595005736: MediBag - 250 mL with neuraxial connectors
• 20857595005125: MediBag - 420 mL
• 20857595005118: MediBag - 250 mL
• 20857595005866: MediBag- 100 mL Dual Port (Needless and Spike Ports)
• 20857595005842: MediBag - 500 mL - Dual Port (Needleless and Spike Ports)
• 20857595005835: MediBag-250 mL Dual Port (Needleless and Spike Ports)
• 10850000509235: MediBag 420 ml w/ Nuraxial Connector