PD-CTTU-600504

GUDID 04589551362943

NAKANISHI INC.

Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable Luminal device flushing tubing set, reusable

• Primary Device ID: 04589551362943
• NIH Device Record Key: 62cb8046-63e9-4da1-835f-a90b58aef88d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PD-CTTU-600504
• Version Model Number: PD-CTTU-600504
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 4
• 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: false
• Lot Batch: false
• 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	04589551354573 [Primary]
GS1	04589551362943 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202120

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

Devices Manufactured by NAKANISHI INC.

• 04560264500730 - Primado2: 2024-04-03
• 04560264500747 - Primado2: 2024-04-03
• 04560264511668 - Primado2: 2024-04-03
• 04560264511675 - Primado2: 2024-04-03
• 04560264511705 - Primado2: 2024-04-03
• 04560264511736 - Primado2: 2024-04-03
• 04560264523081 - Primado2: 2024-04-03
• 04560264523098 - Primado2: 2024-04-03