ROCAFLOW Irrigation, Warming and Suction System MEN02PUS

GUDID 03700512955269

ROCAFLOW US SINGLE CHAMBER WITH SUCTION PUMP FOR OLYMPUS

Promepla

Surgical irrigation/aspiration system

• Primary Device ID: 03700512955269
• NIH Device Record Key: 01ffbc7a-cb1d-402f-a214-6d527d946548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROCAFLOW Irrigation, Warming and Suction System
• Version Model Number: U00000023140
• Catalog Number: MEN02PUS
• 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	03700512955269 [Primary]
GS1	03700512956266 [Package]; 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: 2019-10-18

Devices Manufactured by Promepla

• 03700512921967 - Y-CLIC ADAPTER: 2024-01-15
• 03700512987451 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire: 2024-01-15
• 03700512987468 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire: 2024-01-15
• 03700512987475 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.26cm, without wire: 2024-01-15
• 03700512987482 - LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire: 2024-01-15
• 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