Power Injectable infusion

GUDID 00816513022619

MPS MEDICAL, INC

Medication transfer set

• Primary Device ID: 00816513022619
• NIH Device Record Key: 5f4041db-563b-4050-a7f7-7aa4381388fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Injectable infusion
• Version Model Number: HR-042
• 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	00816513022619 [Primary]
GS1	10816513022616 [Package]; Package: BOX [100 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2019-06-25
• Device Publish Date: 2016-09-14

Devices Manufactured by MPS MEDICAL, INC

• 10816513023422 - Set, I.V. Fluid Transfer: 2021-01-14
• 10816513024573 - Dispenser, Liquid Medication: 2020-12-31
• 10816513025174 - Set, I.V. Fluid Transfer: 2020-12-31
• 10816513025044 - Set, Administration, Intravascular: 2020-04-21
• 10816513025037 - Set, I.V. Fluid Transfer: 2020-04-16
• 10816513024993 - Set, Administration, Intravascular: 2020-03-09
• 10816513025006 - Set, Administration, Intravascular: 2020-03-09
• 10816513025013 - Set, I.V. Fluid Transfer: 2020-03-09