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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Absorbent Tipped Applicators, Sterile	25-806 1PRB	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PC BT	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3000-U E30	EUDAMED	Class I	Active
Collection & Transport System, Sterile	LA-206	EUDAMED	IVD General	Active
Absorbent Tipped Applicators, Sterile	25-3316-U	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PRB 250/10 UNB	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3317-H	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	806-PR	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	8030-PC EX BINDER	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	8060-PC EX BINDER	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-3306-U TT FDNA	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 2PC YELLOW	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3317-H PRT BLACK	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	803-PC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 10WCL	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	816	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1WCB 39/28	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	806-WCL	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	808 BULK	EUDAMED	Class I	Active
Collection & Transport System, Non-Sterile	Ut-117-W	EUDAMED	Class A	Active
Puritan UniTranz-RT	UT-300	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1506 1PFB SLD 20	EUDAMEDFDA UDI	Class I	Active
Puritan	25-800 2PDBG	FDA UDI	Class I	Active
Puritan HydraFlock	25-3316-H EMB 80 BT	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1406 1PF 50	EUDAMEDFDA UDI	Class I	Active
Puritan UniTranz-RT	UT-317	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3206-U 20MM	EUDAMEDFDA UDI	Class I	Active
Puritan Histobrush®	25-2188	EUDAMEDFDA UDI	Class II	Active
Puritan Calgiswab	25-806 1PA	EUDAMEDFDA UDI	Class I	Active
Puritan	25-711 IT	FDA UDI	Class I	Active
Puritan	25-1506 1PF DM	FDA UDI	Class I	Active
Puritan	25-806 2PR	EUDAMEDFDA UDI	Class I	Active
Puritan UniTranz-RT	UT-106	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3318-H	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3317-U BT	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3317-U 20	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1PR BT	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1WC FDNA	EUDAMEDFDA UDI	Class I	Active
Puritan	CB-500	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3316-H	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3606-U BT FABUSA	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3206-H	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3319-H	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3317-H BT	EUDAMEDFDA UDI	Class I	Active
Puritan	25-808 1PR	EUDAMEDFDA UDI	Class I	Active
Puritan	25-803 2WC	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3706-H BT PK	FDA UDI	Class I	Active
Puritan	25-1506 1PF BT BL	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3206-H EMB 33MM PHX	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3306-H	EUDAMEDFDA UDI	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