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Puritan Medical Products Company LLC: FDA-registered device maker in Guilford, ME, United States, 5 510(k) clearances

Name: Puritan Medical Products Company LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Puritan Medical Products Company LLC is registered with the FDA (registration 1216735) in Guilford, ME, United States. It lists 14 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 27, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1216735
Address: 31 School St, Guilford, ME, United States, 04443
Owner or operator: HARDWOOD PRODUCTS COMPANY LP (1216735)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: March 23, 1978
Registered through: 2026
Brand names listed: Brightwood, CaligSwab, Hospital, HydraFlock, Opti-Swab, Opti-Tranz, PurFlock Ultra, PurSwab and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Culture Media, Enriched	KZI	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Culture Media, Selective And Non-Differential	JSJ	1	Manufacturer	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Manufacturer	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization Device	QBD	2	Manufacturer	accessdata.fda.gov
Spatula, Cervical, Cytological	HHT	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Manufacturer	accessdata.fda.gov
System, Transport, Aerobic	JTW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Transport Systems, Anaerobic	JTX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 27, 2025	K242820	Puritan PurSafe Plus Collection and Transport System	QBD	Substantially Equivalent	Puritan Medical Products, LLC	accessdata.fda.gov
November 4, 2016	K162284	Puritan Fecal Opti-Swab Collection and Transport System	JSM	Substantially Equivalent	Puritan Medical Products, LLC	accessdata.fda.gov
June 8, 2012	K120846	TRANSPORT CULTURE MEDIUM DEVICE	LIO	Substantially Equivalent	Puritan Medical Products, LLC	accessdata.fda.gov
March 1, 2012	K113249	TRANSPORT CULTURE MEDIUM DEVICE	JSM	Substantially Equivalent	Puritan Medical Products, LLC	accessdata.fda.gov
January 19, 2012	K111681	HISTOBRUSH	HHT	Substantially Equivalent	Puritan Medical Products Company, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 21, 2024	94087	Class II	Ongoing	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 contained product code 25-3317-U in all packages.	accessdata.fda.gov
December 22, 2014	70270	Class II	Terminated	Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.	Shaft breaks so that adequate patient specimen sample cannot be obtained.	accessdata.fda.gov

Compare with other makers

Updated May 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.