Pure Graft Fat Lock System

GUDID 03701139700249

Promepla

Fluid transfer set, general-purpose

• Primary Device ID: 03701139700249
• NIH Device Record Key: e2b308fe-fe80-4140-ac25-9a49bc5b6e5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure Graft Fat Lock System
• Version Model Number: FLS-5US
• Company DUNS: 401020409
• Company Name: Promepla
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701139700232 [Primary]
GS1	03701139700249 [Package]; Contains: 03701139700232; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• KDQ: Bottle, Collection, Vacuum

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-14
• Device Publish Date: 2020-05-06

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• 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