BioPatch™

GUDID 30705031004348

BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which

Integra Lifesciences Corporation

Exudate-absorbent dressing, non-gel, antimicrobial, sterile

• Primary Device ID: 30705031004348
• NIH Device Record Key: 6135e3eb-fcb1-4311-802a-505f224de12b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPatch™
• Version Model Number: 3151
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 10
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031004344 [Unit of Use]
GS1	20705031004341 [Primary]
GS1	30705031004348 [Package]; Contains: 20705031004341; Package: BOX [4 Units]; In Commercial Distribution
HIBCC	H20631513 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003229

FDA Product Code

• FRO: Dressing, wound, drug

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: 2018-07-06
• Device Publish Date: 2016-06-20

On-Brand Devices [BioPatch™]

• 30705031132911: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031132904: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031132898: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031005253: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031005246: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031005239: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031004355: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031004348: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031004331: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031001125: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031001118: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a
• 30705031001101: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane a