BAROVAC® Evacuator Closed Wound Drainage System(PS)

GUDID 08806369454582

Sewoon Medical Co., Ltd.

Closed-wound drainage kit

• Primary Device ID: 08806369454582
• NIH Device Record Key: e18826b0-481d-4896-94c7-71efd6135d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAROVAC® Evacuator Closed Wound Drainage System(PS)
• Version Model Number: PS400JP(4.8)
• Company DUNS: 687784405
• Company Name: Sewoon Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806369454582 [Primary]

FDA Product Code

• GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [BAROVAC® Evacuator Closed Wound Drainage System(PS)]

• 08806369477864: PS200C2(3.2)
• 08806369455008: PS800L(4.8)
• 08806369454582: PS400JP(4.8)
• 08806369454568: PS400L+(4.8)
• 08806369454544: PS400L(4.8)
• 08806369454520: PS400M+(3.2)
• 08806369454506: PS400M(3.2)
• 08806369454025: PS200M(3.2)
• 08806369454001: PS200C(3.2)