Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Puritan PurSafe Plus Collection and Transport System

K-Number: K242820 · 2025-05-27

ApplicantPuritan Medical Products, LLC
Decision Date2025-05-27
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Puritan PurSafe Plus Collection and Transport System is a medical device manufactured by Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2025-05-27 under approval number K242820. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Puritan PurSafe Plus Collection and Transport System?

Puritan PurSafe Plus Collection and Transport System is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Puritan Medical Products, LLC. The 510(k) number is K242820.

When was Puritan PurSafe Plus Collection and Transport System approved by the FDA?

Puritan PurSafe Plus Collection and Transport System received FDA 510(k) clearance on 2025-05-27, under approval number K242820.

What company makes Puritan PurSafe Plus Collection and Transport System?

Puritan PurSafe Plus Collection and Transport System is manufactured by Puritan Medical Products, LLC.

What is the FDA product code for Puritan PurSafe Plus Collection and Transport System?

The FDA product code for Puritan PurSafe Plus Collection and Transport System is QBD.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT07581301 Administering Atropine Through Autoinjectors Within Ambulance Services for Poisoning Patients in Sri Lanka's North Central Province NOT_YET_RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING

Other Devices by Puritan Medical Products, LLC

K162284Puritan Fecal Opti-Swab Collection and Transport System K160082Puritan Opti-Tranz Cary-Blair Collection and Transport System

Related Devices (Code: QBD)

DEN170029PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC K202641DNA/RNA Shield Collection TubeZymo Research K201849eNAT molecular collection and preservation mediumCopan Italia Spa K210440Disposable Sampler Inactivated Transport Media, Nest ITMWuxi Nest Biotechnology Co., Ltd. K211675Dasky Disposable Sampling Tube (Model name: VSM02)Ningbo Dasky Life Science Co., Ltd. K212113MagXtract Collection TubeMagbio Genomics, Inc.

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.

↑