MediFlo MDE050500

GUDID 10857800006131

MEDIFLO 50ML VOL/50ML HR 48/CS

NDC HOMECARE LLC

Elastomeric infusion pump system

• Primary Device ID: 10857800006131
• NIH Device Record Key: 54c32015-bc1b-4142-a41c-e517a4cf6d1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediFlo
• Version Model Number: MDE050500
• Catalog Number: MDE050500
• Company DUNS: 939966016
• Company Name: NDC HOMECARE LLC
• 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: true
• 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	00857800006134 [Primary]
GS1	10857800006131 [Package]; Contains: 00857800006134; Package: Case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151650

FDA Product Code

• MEB: Pump, Infusion, Elastomeric

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: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [MediFlo]

• 10857800006513: MEDIFLO 250ML VOL/250ML HR 24/CS
• 10857800006452: MEDIFLO 250ML VOL/175ML HR 24/CS
• 10857800006438: MEDIFLO 100ML VOL/200ML HR 48/CS
• 10857800006414: MEDIFLO 100ML VOL/100ML HR 48/CS
• 10857800006131: MEDIFLO 50ML VOL/50ML HR 48/CS
• 10850007185692: MEDIFLO 270ML VOL/ 175ML HR 24/CS
• 10850007185319: MEDIFLO 200ML VOL/ 100ML HR 24/CS
• 10850007185302: MEDIFLO 300ML VOL/ 6ML HR 24/CS
• 00850007185237: MEDIFLO 250ML VOL/2ML HR 24/CS
• 10850007185173: MEDIFLO 200ML VOL/200ML HR 24/CS
• 10850007185166: MEDIFLO 250ML VOL/50ML HR 24/CS
• 10850007185159: MEDIFLO 250ML VOL/125ML HR 24/CS
• 10850007185142: MEDIFLO 500ML VOL/20ML HR 24/CS
• 10850007185135: MEDIFLO 250ML VOL/500ML HR 24/CS
• 10850007185128: MEDIFLO 270ML VOL/2ML HR 24/CS
• 10850007185111: MEDIFLO 100ML VOL/50ML HR 48/CS
• 10850007185104: MEDIFLO 270ML VOL/5ML HR 24/CS
• 10850007185098: MEDIFLO 100ML VOL/2ML HR 24/CS
• 10850007185081: MEDIFLO 250ML VOL/100ML HR 24/CS
• 10850007185074: MEDIFLO 270ML VOL/1ML HR 24/CS
• 10850007185067: MEDIFLO 270ML VOL/10ML HR 24/CS
• 10850007185050: MEDIFLO 500ML VOL/250ML HR 24/CS
• 10850007185043: MEDIFLO 400ML VOL/100ML HR 24/CS
• 10850007185036: MEDIFLO 100ML VOL/2ML HR 24/CS
• 10850007185029: MEDIFLO 270ML VOL/5ML HR 24/CS
• 10850007185012: MEDIFLO 270ML VOL/10ML HR 24/CS
• 10850007185005: MEDIFLO 400ML VOL/100ML HR 24/CS