Is this your brand? Sign in to claim ownership.

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 4 of 5

Device	Model / Reference	Registries	Class	Status
Puritan	25-1000 1PD	FDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3316-U BT	EUDAMEDFDA UDI	Class I	Active
Puritan Histobrush Cytology Brush	Histobrush	EUDAMEDFDA UDI	Class II	Active
Puritan	25-806 1PRLB	FDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3706-U	FDA UDI	Class I	Active
Rovers EndoCervex Brush	2195	FDA UDI	Class II	Active
Puritan Opti-Swab	LA-116 (3316-H)	FDA UDI	Class I	Active
Puritan Cap-Shure	25-806 1PC EC	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3206-H EMB 50MM	FDA UDI	Class I	Active
Puritan HydraFlock	25-3206-H EMB 50MM PRT	FDA UDI	Class I	Active
Puritan UniTranz-RT	UT-117	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3316-H BT	FDA UDI	Class I	Active
Puritan	25-1506 1PF BT	EUDAMEDFDA UDI	Class I	Active
Puritan	25-800 1PD ALUM 50	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1PR	FDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3206-U	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3306-H 100/13	FDA UDI	Class I	Active
Puritan FAB-SWAB	25-805 1PC TT FABUSA	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1805 1PF RND	EUDAMEDFDA UDI	Class I	Active
Puritan	25-800 D 50	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3320-U	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1506 1PFB SMO SC 79MM	FDA UDI	Class I	Active
Puritan	25-1597 10PF	FDA UDI	Class I	Active
Puritan UniTranz-RT	UT-362	FDA UDI	Class I	Active
Puritan HydraFlock	25-3320-H EMB 80MM	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 1WC	FDA UDI	Class I	Active
Puritan	25-826 5WC	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 2PR BT	EUDAMEDFDA UDI	Class I	Active
Puritan UniTranz-RT	UT-306	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3319-H BT	EUDAMEDFDA UDI	Class I	Active
Puritan	25-1406 1PF TT MC 50	FDA UDI	Class I	Active
Puritan	25-806 1PDS SC	FDA UDI	Class I	Active
Puritan Calgiswab	25-806 2WA	FDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3506-U	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3000-H E30	EUDAMEDFDA UDI	Class I	Active
Puritan	25-806 2PC BLUE	EUDAMEDFDA UDI	Class I	Active
Puritan	25-800 2PDB	FDA UDI	Class I	Active
Puritan	25-1805 1PF RND FDNA	EUDAMEDFDA UDI	Class I	Active
Puritan HydraFlock	25-3318-H BT	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3306-U	EUDAMEDFDA UDI	Class I	Active
Puritan FAB-SWAB	25-806 1PC BT FABUSA-1GR	FDA UDI	Class I	Active
Histobrush® Cytology Brush	2188	FDA UDI	Class II	Active
Puritan UniTranz-RT	UT-316	EUDAMEDFDA UDI	Class I	Active
Puritan Calgiswab	25-800 A 50	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3320-U EMB 80MM	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3806-U	FDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3318-U BT	EUDAMEDFDA UDI	Class I	Active
Puritan PurFlock Ultra	25-3316-U EMB 79.5MM	FDA UDI	Class I	Active
Puritan Opti-Swab	CB-206 (25-3506-H)	FDA UDI	Class I	Active
Puritan Histobrush	25-2199	EUDAMEDFDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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