Set, Transfer & Flood, Blood

GUDID 10816513024535

MPS MEDICAL, INC

Medication transfer set

• Primary Device ID: 10816513024535
• NIH Device Record Key: 53ca1edf-07a2-4f23-be0e-e7646507c4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set, Transfer & Flood, Blood
• Version Model Number: BTF-HM-3
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816513024538 [Primary]
GS1	10816513024535 [Package]; Contains: 00816513024538; Package: BOX [50 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-06

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