EXTENSION SET

GUDID 00810080610323

MPS Pharma & Medical, Inc.

Intravenous administration tubing extension set

• Primary Device ID: 00810080610323
• NIH Device Record Key: 3b584f67-234a-4aa6-844d-d8d833be7fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTENSION SET
• Version Model Number: EB-072-01
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810080610323 [Primary]
GS1	10810080610320 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955896

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: 2022-09-01
• Device Publish Date: 2022-08-24

Devices Manufactured by MPS Pharma & Medical, Inc.

• 10810110921389 - Mini Transfer Pin: 2025-05-06 Mini Transfer Pin
• 10810080612447 - DROPPER BOTTLE SYSTEM: 2025-05-02 15-415 Series 5mL Dropper Bottle Natural, Cylinder Round Tray
• 10810080612454 - DROPPER BOTTLE SYSTEM: 2025-05-02 15-415 Series 5ml Dropper Bottle, Natural Cylinder Round
• 10810080612478 - SAFEFILL™: 2025-04-23 15-415 Series SafeFill™ 10ML Dropper Bottle, Natural Boston Round Tray
• 00810080612310 - OptiDropper™: 2025-02-12 OptiDropper™ 3ML STERILE DROPPER BOTTLE
• 10810080611761 - DROPPER BOTTLE TIP SYSTEM: 2024-09-27 TE 15MM DROPPER BOTTLE TIP - WHITE
• 10810080611778 - DROPPER BOTTLE CAP SYSTEM: 2024-09-27 TE BOTTLE SYSTEM TE CAP RED
• 10810080611785 - DROPPER BOTTLE CAP SYSTEM: 2024-09-27 TE BOTTLE SYSTEM TE CAP PURPLE