RocaFlow Irrigation warming System MEN01

GUDID 03700512956181

ENDOFLOW II - Single Chamber Olympus

Promepla

Surgical irrigation/aspiration system

• Primary Device ID: 03700512956181
• NIH Device Record Key: 9840e2e5-087b-4e0c-a93d-fa9745c946a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RocaFlow Irrigation warming System
• Version Model Number: MEN01US-245
• Catalog Number: MEN01
• Company DUNS: 401020409
• Company Name: Promepla
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	03700512955184 [Primary]
GS1	03700512956181 [Package]; Contains: 03700512955184; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152278

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-10-29

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• 03700512987499 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.30cm, without wire: 2024-01-15
• 03700512987505 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.24cm, without wire: 2024-01-15
• 03700512977513 - LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.26cm, without wire: 2024-01-15