FLOW-EZE VENTED NEEDLE

GUDID 10810080610030

MPS Pharma & Medical, Inc.

Medication transfer set

• Primary Device ID: 10810080610030
• NIH Device Record Key: 1b06cc5b-ac0c-449d-9159-61bc59ef2d5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOW-EZE VENTED NEEDLE
• Version Model Number: 19B
• Company DUNS: 117970217
• Company Name: MPS Pharma & Medical, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810080610033 [Primary]
GS1	10810080610030 [Package]; Contains: 00810080610033; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853212

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

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: 2022-08-26
• Device Publish Date: 2022-08-18

Devices Manufactured by MPS Pharma & Medical, Inc.

• 10810080612379 - OptiDropper™: 2025-05-21 OptiDropper™ 15ML Sterile Dropper Bottle
• 10810080612324 - OptiDropper™: 2025-05-20 OptiDropper™ 3ML Sterile Dropper Bottle
• 10810080612331 - OptiDropper™: 2025-05-20 OptiDropper™ 3ML Sterile Dropper Bottle
• 10810080612348 - OptiDropper™: 2025-05-20 OptiDropper™ 7ML Sterile Dropper Bottle
• 10810080612355 - OptiDropper™: 2025-05-20 OptiDropper™ 7ML Sterile Dropper Bottle
• 10810080612362 - OptiDropper™: 2025-05-20 OptiDropper™ 15ML Sterile Dropper Bottle
• 10810080612386 - OptiDropper™: 2025-05-20 OptiDropper™ 15ML Sterile Dropper Bottle Cylinder Round Bottle, Red Cap
• 10810080612393 - OptiDropper™: 2025-05-20 OptiDropper™ 15ML Sterile Dropper Bottle