ProV-Access Non-Sterile Vascular Access Needle Guides 5434

GUDID 10841912104540

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 10841912104540
• NIH Device Record Key: 2278171c-79bb-473f-842a-08e3d6984637
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProV-Access Non-Sterile Vascular Access Needle Guides
• Version Model Number: 5434
• Catalog Number: 5434
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 300
• 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: true
• Expiration Date: false
• 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	00841912104543 [Unit of Use]
GS1	10841912104540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973958

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-23

On-Brand Devices [ProV-Access Non-Sterile Vascular Access Needle Guides]

• 10841912104557: 5436
• 10841912104540: 5434