Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1216735

FEI Number

1216735

Entity Name

PURITAN MEDICAL PRODUCTS COMPANY LLC

City/State/Country

GUILFORD, ME, US

Establishment Address

31 School St, GUILFORD, ME 04443, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HARDWOOD PRODUCTS COMPANY LP (Owner Number: 1216735)

Owner / Operator Contact Address

31 SCHOOL ST., P.O. BOX 149, Guilford, ME 04443, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Puritan Medical Products Company LLC PureSafe Plus Puritan Puritan Puritan Medical Products Company LLC Opti-Tranz Opti-Swab HydraFlock PurSwab PurFlock Ultra CaligSwab Puritan, Pur-Wraps Brightwood Puritan, Pur-Wraps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-10-21
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2026-01-19
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2012-03-06
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2012-03-06
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2023-03-31
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2013-11-01
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2013-11-01
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2013-11-01
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2010-06-22
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1978-03-23

Official Correspondent

Kevin Wrigley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HARDWOOD PRODUCTS COMPANY LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017206126	PURITAN MEDICAL PRODUCTS, LLC	Pittsfield, ME, US
3018490419	Puritan Medical Products Company, LLC	Pittsfield, ME, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

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3023344913	AR ORTHOPEDICS, LLC	Newberry, FL, US
3041725026	Fill Mill	Lakewood, NJ, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1216735. Last updated year: 2026. Please use registration number 1216735 when referencing this establishment in official correspondence.