AVELLE 422285

GUDID 00768455155040

Avelle™ Negative Pressure Wound Therapy Pump X6 Battery Pack

CONVATEC, PURCHASING DEPARTMENT

Negative-pressure wound therapy system dressing set

• Primary Device ID: 00768455155040
• NIH Device Record Key: 10161fc3-32e3-4406-af21-b1a8133b224a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVELLE
• Version Model Number: 422285
• Catalog Number: 422285
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455155033 [Primary]
GS1	00768455155040 [Package]; Contains: 00768455155033; Package: Inner Carton [1 Units]; In Commercial Distribution
GS1	10768455155047 [Package]; Package: Shipper [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180205

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [AVELLE]

• 00768455155040: Avelle™ Negative Pressure Wound Therapy Pump X6 Battery Pack
• 00768455154357: Avelle™ Negative Pressure Wound Therapy Dressing 26X26Cm
• 00768455154340: Avelle™ Negative Pressure Wound Therapy Dressing 21X26Cm
• 00768455154333: Avelle™ Negative Pressure Wound Therapy Dressing 12X41Cm
• 00768455148905: Avelle™ Negative Pressure Wound Therapy Dressing 12X31Cm
• 00768455148899: Avelle™ Negative Pressure Wound Therapy Dressing 12X21Cm
• 00768455148882: Avelle™ Negative Pressure Wound Therapy Dressing 16X21Cm
• 00768455148875: Avelle™ Negative Pressure Wound Therapy Dressing 16X16Cm
• 00768455149070: Avelle™ Negative Pressure Wound Therapy Carry Bag