MediBag 220529

GUDID 20857595005835

MediBag-250 mL Dual Port (Needleless and Spike Ports)

SUMMIT MEDICAL PRODUCTS, INC.

Parenteral/enteral solution bag

• Primary Device ID: 20857595005835
• NIH Device Record Key: d61f2f75-e861-4024-b384-52dbc7b93dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediBag
• Version Model Number: 220529
• Catalog Number: 220529
• 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: 250 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857595005831 [Primary]
GS1	10857595005838 [Package]; Contains: 00857595005831; Package: [30 Units]; In Commercial Distribution
GS1	20857595005835 [Package]; Contains: 00857595005831; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-13
• Device Publish Date: 2019-09-05

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