Set Administration Intravascular

GUDID 00816513022497

MPS MEDICAL, INC

Medication transfer set

• Primary Device ID: 00816513022497
• NIH Device Record Key: c20ff706-3756-452e-943d-b570c7da7a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set Administration Intravascular
• Version Model Number: DB-008-04
• 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	00816513022497 [Primary]
GS1	10816513022494 [Package]; Package: BOX [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982587

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: 2016-09-12

On-Brand Devices [Set Administration Intravascular]

• 00816513022602: SM-007
• 00816513022596: NP-003
• 00816513022589: HR-015-BS
• 00816513022572: FL1002-FM
• 00816513022565: EG-016-05
• 00816513022541: EB-038-12
• 00816513022510: DD-001-28
• 00816513022497: DB-008-04
• 10816513023958: BGI-BC105
• 10816513023859: KMI-CL-LLP
• 10816513024863: DB-009-01