Power Injectable infusion set

GUDID 00816513023548

MPS MEDICAL, INC

Medication transfer set Medication transfer set Medication transfer set

• Primary Device ID: 00816513023548
• NIH Device Record Key: 9610125d-3397-4784-9c0f-5e94ec1f0f0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Injectable infusion set
• Version Model Number: TID-B
• Company DUNS: 079636164
• Company Name: MPS 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	00816513023548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090809

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-30

On-Brand Devices [Power Injectable infusion set ]

• 00816513023548: TID-B
• 00816513022664: HR-044
• 00816513022633: HR042B