Angel Catheter

GUDID 15711055005002

SHORT-TERM INTRAVASCULAR FILTER CATHETER

Mermaid Medical A/S

Vena cava filter, temporary/permanent
Primary Device ID15711055005002
NIH Device Record Keyf34280b3-db7e-4da0-8164-59bbc2990ca6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngel Catheter
Version Model NumberAC3930A
Company DUNS308951313
Company NameMermaid Medical A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115711055005002 [Primary]
GS125711055005009 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNSShort-Term Intravascular Filter Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-06
Device Publish Date2022-09-28

Devices Manufactured by Mermaid Medical A/S

25711055100407 - M-Drain2024-10-09 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
25711055110048 - M-Drain2024-07-29 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
25711055110406 - M-Drain2024-07-29 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
25711055120047 - M-Drain2024-02-08 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
25711055120450 - M-Drain2024-02-08 The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and
25711055001520 - M-Biopsy Needle For Reusable Biopsy Instruments2023-10-11 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 Instruments2023-10-11 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 Instruments2023-10-11 The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate,

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