PICO 66021365

GUDID 05000223491086

PICO 25cm x 25cm Dual Dressing Kit US

SMITH & NEPHEW MEDICAL LIMITED

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

• Primary Device ID: 05000223491086
• NIH Device Record Key: 6ac96ece-bc24-4312-9520-9d1500caa67b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICO
• Version Model Number: 66021365
• Catalog Number: 66021365
• 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: 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	05000223491086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172519

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-22

On-Brand Devices [PICO]

• 05000223491086: PICO 25cm x 25cm Dual Dressing Kit US
• 05000223491079: PICO 20cm x 20cm Dual Dressing Kit US
• 05000223491062: PICO 15cm x 30cm Dual Dressing Kit US
• 05000223491055: PICO 15cm x 20cm Dual Dressing Kit US
• 05000223491048: PICO 15cm x 15cm Dual Dressing Kit US
• 05000223491031: PICO 10cm x 40cm Dual Dressing Kit US
• 05000223491024: PICO 10cm x 30cm Dual Dressing Kit US
• 05000223491017: PICO 10cm x 20cm Dual Dressing Kit US
• 05000223477219: PICO Single Use Negative Pressure Wound Therapy System 25cm x 25cm 10in. X 10in.
• 05000223477196: PICO Single Use Negative Pressure Wound Therapy System 20cm x 20cm 8in. X 8in.
• 05000223477172: PICO Single Use Negative Pressure Wound Therapy System 15cm x 30cm 6in. X 12in.
• 05000223477141: PICO Single Use Negative Pressure Wound Therapy System 15cm x 15cm 6in. X 6in.
• 05000223477110: PICO Single Use Negative Pressure Wound Therapy System 10cm X 40cm 4in. X 16in.
• 05000223477097: PICO Single Use Negative Pressure Wound Therapy System 10cm x 30cm 4in. x 12in.
• 05000223477080: PICO Single Use Negative Pressure Wound Therapy System 10cm x 20cm 4in. x 8in.
• 05000223477158: PICO Single Use Negative Pressure Wound Therapy System 15cm x 20cm 6in. x 8in.