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FDA 510(k)

CPR URINE BAG

K-Number: K960217 · 1996-03-28

ApplicantCustom Pack Reliability
Decision Date1996-03-28
Product CodeFAQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CPR URINE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Custom Pack Reliability. It received FDA 510(k) clearance on 1996-03-28 under 510(k) number K960217. The device is classified under product code FAQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPR URINE BAG?

CPR URINE BAG is a medical device that received FDA 510(k) clearance on 1996-03-28. The listed applicant is Custom Pack Reliability. The 510(k) number is K960217.

When did CPR URINE BAG receive FDA 510(k) clearance?

CPR URINE BAG received FDA 510(k) clearance on 1996-03-28, under 510(k) number K960217.

Who is the listed applicant for CPR URINE BAG?

The FDA 510(k) record lists Custom Pack Reliability as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPR URINE BAG?

The FDA product code for CPR URINE BAG is FAQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Custom Pack Reliability as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960205CPR TRACHEOTOMY CARE TRAYK960243CPR C-SECTION DELIVERY PACKK960239CPR D & C TRAYK960216CPR SUCTION CATHETER KITK960210CPR ORTHO HAND PACKK960206CPR DRESSING CHANGE TRAY

View all 21 devices →

Related Devices (Code: FAQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & SonsK955609CONVEEN URINE BAG - STERILEColoplast Corp.K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & SonsK953783CONVEEN LEG BAG STRAPColoplast Corp.K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & SonsK945204URINE COLLECTOR & ACCESSORIESNelmed Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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