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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 1 of 5

Device	Model / Reference	Registries	Class	Status
Absorbent Tipped Applicators, Sterile	25-3317-H 20	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-1516 1PF SOLID CELLMARK	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	806-PPR	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PRB 80/30	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 2PD TT	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	803-WCL	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	876-WC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3318-U	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PDB FP 7.5	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 2PR TT	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	806-PC 145MM	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 2PC PINK	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	808-PR EX BINDER	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	821-WC	EUDAMED	Class I	Active
Collection & Transport System, Sterile	LA-106	EUDAMED	IVD General	Active
Absorbent Tipped Applicators, Non-Sterile	1806-1PCF/1PCSF HS	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3316-H	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 2WC TT FDNA	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3317-U NYL	EUDAMED	Class I	Active
Collection & Transport System, Sterile	LA-117	EUDAMED	IVD General	Active
Absorbent Tipped Applicators, Sterile	25-3206 2H	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-3206-H EC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	826-WC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	816 BULK	EUDAMED	Class I	Active
Transport Media	SP-100 P	EUDAMED	Class A	Active
Absorbent Tipped Applicators, Non-Sterile	3316-U EMB 79MM RING	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3406-U	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PDB	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-3606-U BT	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3316-H EMB 79.5MM	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PD BT	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	869-WCS	EUDAMED	Class I	Active
Cervical Cytology Devices, Sterile	25-2199 MTL-01932	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PDB SLD ABON	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-1503 1PFB SOLID	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3806-U EMB 79.5MM	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-3306-H BT	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-3320-U 20	EUDAMED	Class I	Active
Collection & Transport System, Sterile	LA-116	EUDAMED	IVD General	Active
Absorbent Tipped Applicators, Non-Sterile	868-WCS	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	806-PC SOLID S	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	803-WC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	823-WC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3317-H PRT RED	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	3206-H	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-806 1PDS BINAX	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	808	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Sterile	25-1506 1PF TT MC	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	806-PA 5M	EUDAMED	Class I	Active
Absorbent Tipped Applicators, Non-Sterile	8060-WC EX BINDER	EUDAMED	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