PICC Guard 2051720518

GUDID B38320517205181

Tamper-evident catheter access cover

PICCGUARD, LLC

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• Primary Device ID: B38320517205181
• NIH Device Record Key: beef35ba-1cfa-4f2b-96c4-f204f6902afb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICC Guard
• Version Model Number: 1
• Catalog Number: 2051720518
• Company DUNS: 117382745
• Company Name: PICCGUARD, 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: 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

Customer Support Contacts

• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com
• Phone: 9185192563
• Email: info@piccguard.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B38320517205181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191195

FDA Product Code

• PZW: Catheter Access Cover, Tamper-Resistant

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-06
• Device Publish Date: 2020-06-28

On-Brand Devices [PICC Guard]

• B38320517205181: Tamper-evident catheter access cover
• B38320517205182: Tamper-Evident Catheter Access Cover