Chrysalis Intelligence · Sponsors · Puritan Medical Products, LLC

Puritan Medical Products, LLC

Guilford, ME, US · 1 510(k) clearances · 1 recalls

Total clearances
1
2025-05-27 → 2025-05-27
Last 12 months
0
Product codes
1
Most recent
2025-05-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QBD Microbial Nucleic Acid Storage And Stabilization Device Class II Microbiology 1 2025-05-27
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2024-02-21
DateSeverityStatusRecall # ProductCodeReason
2024-02-21 Class II Ongoing Z-1391-2024 HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contai…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2025-05-27 K242820 Puritan PurSafe Plus Collection and Transport System QBD Class II Microbiology