Angel Catheter

GUDID 15711055005002

SHORT-TERM INTRAVASCULAR FILTER CATHETER

Mermaid Medical A/S

Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent Vena cava filter, temporary/permanent

• Primary Device ID: 15711055005002
• NIH Device Record Key: f34280b3-db7e-4da0-8164-59bbc2990ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angel Catheter
• Version Model Number: AC3930A
• Company DUNS: 308951313
• Company Name: Mermaid Medical A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15711055005002 [Primary]
GS1	25711055005009 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160747

FDA Product Code

• PNS: Short-Term Intravascular Filter Catheter

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: 2022-10-06
• Device Publish Date: 2022-09-28

Devices Manufactured by Mermaid Medical A/S

• 25711055120047 - M-Drain: 2024-02-08 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
• 25711055120450 - M-Drain: 2024-02-08 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
• 25711055001520 - M-Biopsy Needle For Reusable Biopsy Instruments: 2023-10-11 The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast,
• 25711055001643 - M-Biopsy Needle For Reusable Biopsy Instruments: 2023-10-11 The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate,
• 25711055001698 - M-Biopsy Needle For Reusable Biopsy Instruments: 2023-10-11 The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate,
• 25711055001759 - M-Biopsy Needle For Reusable Biopsy Instruments: 2023-10-11 The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate,
• 25711055001223 - M-Biopsy Needle For Reusable Biopsy Instruments: 2023-10-04 The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast,
• 25711055001230 - M-Biopsy Needle For Reusable Biopsy Instruments: 2023-10-04 The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast,