ExtriCARE EC2400-IM-E

GUDID 14897089070122

Extricare Extra Large Oval Dressing

ALLEVA MEDICAL LIMITED

Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial Negative-pressure wound therapy system foam dressing, non-antimicrobial

• Primary Device ID: 14897089070122
• NIH Device Record Key: 7f10d054-cbda-418b-b417-084aa80d2ad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExtriCARE
• Version Model Number: ST394-0001
• Catalog Number: EC2400-IM-E
• Company DUNS: 669361099
• Company Name: ALLEVA MEDICAL LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897089070125 [Primary]
GS1	14897089070122 [Package]; Contains: 04897089070125; Package: Shipper [15 Units]; In Commercial Distribution
GS1	24897089070129 [Package]; Package: Case [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110078

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

[14897089070122]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [ExtriCARE]

• 14897089070788: ExtriCARE 3000 Negative Pressure Wound Therapy Pump
• 14897089070412: Extricare Medium Foam Dressing Kit
• 14897089070320: Extricare 1000 Negative Pressure Wound Therapy Pump
• 14897089070191: Extricare 3600 Negative Pressure Wound Therapy Pump
• 14897089070177: Extricare Mini Oval Dressing
• 14897089070153: Extricare Large Foam Dressing Kit
• 14897089070146: Extricare Small Foam Dressing
• 14897089070092: Extricare Small Oval Dressing
• 14897089070054: Extricare 3600 400cc Canister
• 14897089070047: Extricare 3600 1000cc Canister
• 14897089070122: Extricare Extra Large Oval Dressing
• 14897089070474: ExtriCARE 1000 50cc canister
• 14897089070375: 400cc Canister for Extricare 3000 pump
• 14897089070368: Extricare 3000 pump 100cc Canister
• 14897089070214: Negative Pressure Wound Therapy Drape - 33.5x32cm