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PURITAN MEDICAL PRODUCTS COMPANY LLC

United States·US-MF-000007051

Last updated September 17, 2026

Information

Country: United States
Address: 31, School Street, Guilford, United States
Website: www.puritanmedproducts.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 207 876 3311
PRRC Contact: Kevin Wrigley
EUDAMED SRN: US-MF-000007051
FDA FEI Number: 1216735
DUNS Number: —

Catalogue (244)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Puritan	25-806 1WR	FDA UDI	Class I	Active
Puritan	25-806 1PD SC 2 1/2	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3316-H EMB 79.5MM	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1PDB 1500	FDA UDI	Class I	Active
Puritan Calgiswab	25-806 1WA	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3316-H 60MM PRT	FDA UDI	Class I	Active
Puritan UniTranz-RT	UT-302	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3320-U EMB 100MM	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 2PD SC 3.875	FDA UDI	Class I	Active
Puritan	25-805 1PR	FDA UDI	Class I	Active
Puritan UniTranz-RT	UT-116	FDA UDI	Class I	Active
Puritan FAB-SWAB	25-806 1PC BT FABUSA	EUDAMEDFDA UDI	Class I	Active
Puritan	LB-200	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1616 1PF	EUDAMEDFDA UDI	Class I	Active
Puritan	25-700	FDA UDI	Class I	Active
Puritan	25-806 1WD	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3506-H	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1PDB UNBRK	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3406-H BT	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1PD 7.5	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3206-H 20MM BT	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3606-U BT FABUSA-1	FDA UDI	Class I	Active
Puritan HydraFlock	25-3316-H EMB 100 BT	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3806-H BT PK	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1506 1PF SOLID	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3706-H	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3318-U	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3806-H BT	FDA UDI	Class I	Active
Puritan HydraFlock	25-3606-H	EUDAMEDFDA UDI	Class I	Active
CerfiSoft Foam Cytology Collection Swab	2197	FDA UDI	Class II	Active
Puritan HydraFlock	25-3606-H BT	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3206-H 20MM	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3706-U BT	FDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3406-U	EUDAMEDFDA UDI	Class I	Active
Puritan UniTranz-RT	UT-366	EUDAMEDFDA UDI	Class I	Active
PurSwab	25-1605 1PSF RECT	FDA UDI	Class I	Active
Puritan PurSafe Plus Collection and Transport System	K242820	FDA 510(k)	Class II	Active
Transport Culture Medium Device	K113249	FDA 510(k)	Class I	Active
Puritan Fecal Opti-Swab Collection and Transport System	K162284	FDA 510(k)	Class I	Active
Puritan Amies Medium Collection And Transport System	K131630	FDA 510(k)	Class I	Active
Histobrush	K111681	FDA 510(k)	Class II	Active
Puritan Opti-Tranz Cary-Blair Collection and Transport System	K160082	FDA 510(k)	Class I	Active
Puritan OptiTranz Liquid Stuart Collection and Transport System	K142366	FDA 510(k)	Class I	Active
Transport Culture Medium Device	K120846	FDA 510(k)	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 21, 2024	Z-1391-2024	—	open, classified	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.
Dec 22, 2014	Z-1278-2015	—	terminated	Shaft breaks so that adequate patient specimen sample cannot be obtained.
Dec 2, 2003	Z-0317-04	—	terminated	Oxygen component is out of specification