Pico 14 66022044

GUDID 05000223495404

PICO 14 10cm x 40cm US CTN1

SMITH & NEPHEW MEDICAL LIMITED

Negative-pressure wound therapy system, battery-powered, single-use

• Primary Device ID: 05000223495404
• NIH Device Record Key: 8afdde09-7e2e-4d8a-97f3-cb9788431916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pico 14
• Version Model Number: 66022044
• Catalog Number: 66022044
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223495404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191760

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-08
• Device Publish Date: 2019-12-19

On-Brand Devices [Pico 14]

• 05000223495473: PICO 14 MULTISITE LARGE 20X25CM US
• 05000223495466: PICO 14 MULTISITE SMALL 15x20cm CTN1
• 05000223495459: PICO 14 25cm x 25cm US CTN1
• 05000223495442: PICO 14 20cm x 20cm US CTN1
• 05000223495435: PICO 14 15cm x 30cm US CTN1
• 05000223495428: PICO 14 15cm x 20cm US CTN1
• 05000223495411: PICO 15cm x 15cm US CTN1
• 05000223495404: PICO 14 10cm x 40cm US CTN1
• 05000223495398: PICO 14 10cm x 30cm US CTN1
• 05000223495381: PICO 14 10cm x 20cm US