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

• 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