PICC WAND 91012

GUDID 30859821006156

The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

ACCESS SCIENTIFIC, LLC

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable

• Primary Device ID: 30859821006156
• NIH Device Record Key: 4e8a7088-c664-48bf-bb39-8042412b3775
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICC WAND
• Version Model Number: 6Fr
• Catalog Number: 91012
• Company DUNS: 079290879
• Company Name: ACCESS SCIENTIFIC, LLC
• 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: 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 Dimensions

• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French
• Length: 7 Centimeter
• Catheter Gauge: 6 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10859821006152 [Primary]
GS1	20859821006159 [Package]; Contains: 10859821006152; Package: Carton [10 Units]; In Commercial Distribution
GS1	30859821006156 [Package]; Contains: 20859821006159; Package: Overpack [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111138

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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-09

On-Brand Devices [PICC WAND]

• 20859821006418: PICC WAND Max Barrier Kit 6Fr
• 20859821006401: PICC WAND Max Barrier Kit 5Fr
• 20859821006395: PICC WAND Max Barrier Kit 4Fr
• 30859821006156: The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
• 30859821006149: The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
• 30859821006132: The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection