FDA device listing

Storz Disp High Flow Insufflation Tbg w/Filter #20400161S,Storz Disp High Flow Insufflation Tbg w/Filter #20400162S

FDA device listing 1049569565 · NBS GROUP SUPPLY- MEDICAL PRODUCTS DIVISION, LLC

Key facts

Proprietary names Storz Disp High Flow Insufflation Tbg w/Filter #20400161S,Storz Disp High Flow Insufflation Tbg w/Filter #20400162S
Owner/operator NBS GROUP SUPPLY- MEDICAL PRODUCTS DIVISION, LLC
Owner/operator number 9040634
Premarket submissions K001068
Product codes GCJ, HIF, JCX, KNX
Device names GCJ - Laparoscope, General & Plastic Surgery, HIF - Insufflator, Laparoscopic, JCX - Apparatus, Suction, Ward Use, Portable, Ac-Powered, KNX - Collector, Urine, (And Accessories) For Indwelling Catheter
Device class Class II
Classification regulations (21 CFR) 876.1500, 876.5250, 878.4780, 884.1730
Review panels Gastroenterology & Urology, General & Plastic Surgery, Obstetrics/Gynecology
Registered establishments NBS GROUP SUPPLY- MEDICAL PRODUCTS DIVISION, LLC
Establishment registrations 2249651
FEI numbers 3002771993
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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