Flowguard™ 10684-005

GUDID 10821329500074

Valved Peelable Introducer

Greatbatch Ltd

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10821329500074
• NIH Device Record Key: b7693885-22e0-4cb0-804b-6ba9171165a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flowguard™
• Version Model Number: 10684-005
• Catalog Number: 10684-005
• Company DUNS: 968623467
• Company Name: Greatbatch Ltd
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 14.2 Centimeter
• Length: 14.2 Centimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter
• Catheter Gauge: 8 French
• Lumen/Inner Diameter: 2.8 Millimeter
• Length: 14.2 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00082132950071 [Primary]
GS1	00821329500077 [Primary]
GS1	10821329500074 [Package]; Contains: 00821329500077; Package: BOX [5 Units]; In Commercial Distribution

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-02
• Device Publish Date: 2016-09-24

On-Brand Devices [Flowguard™]

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• 10821329500074: Valved Peelable Introducer
• 10821329500081: Valved Peelable Introducer
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• 10821329500050: Valved Peelable Introducer
• 10821329500043: Valved Peelable Introducer
• 10821329500036: Valved Peelable Introducer
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• 10821329400534: Valved Peelable Introducer
• 10821329400527: Valved Peelable Introducer
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• 10821329400503: Valved Peelable Introducer
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• 10821329400466: Valved Peelable Introducer
• 00821329400452: Valved Peelable Introducer
• 00821329400445: Valved Peelable Introducer
• 00821329400438: Valved Peelable Introducer
• 00821329400421: Valved Peelable Introducer
• 10821329400183: Valved Peelable Introducer
• 10821329400176: Valved Peelable Introducer
• 10821329400169: Valved Peelable Introducer
• 10821329400152: Valved Peelable Introducer
• 00821329400117: Valved Peelable Introducer
• 00821329400100: Valved Peelable Introducer
• 00821329400094: Valved Peelable Introducer
• 00821329400087: Valved Peelable Introducer