Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPURITAN 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
- —
- —
- [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 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Puritan | 25-1406 1PFB | FDA UDI | Class I | Active |
| Puritan Cap-Shure | 25-806 1WC EC | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 1PC | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-1406 1PF BT | FDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3606-U | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-705 | EUDAMEDFDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3806-U 3.25 BIOLIFE | EUDAMEDFDA UDI | Class I | Active |
| Puritan UniTranz-RT | UT-367 | EUDAMEDFDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3806-U BT | FDA UDI | Class I | Active |
| Puritan | 25-800 1PD 50 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-711 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | CB-200 | EUDAMEDFDA UDI | Class I | Active |
| Puritan Opti-Swab | LA-106 (3506-H) | FDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3320-H EMB 100MM | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-803 2PC | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-1506 1PFB | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 1PD SOLID | EUDAMEDFDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3706-H BT | EUDAMEDFDA UDI | Class I | Active |
| Puritan | SP-100 | FDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3406-U BT | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-1506 1PF 100 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-800 R 50 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 2PD | EUDAMEDFDA UDI | Class I | Active |
| Puritan UniTranz-RT | UT-100 | EUDAMEDFDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3406-U RIB PRT SC 20MM | EUDAMEDFDA UDI | Class I | Active |
| Puritan Opti-Swab | LA-117 (3317-H) | FDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3000-U E30 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-826 2WD | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 10WC | FDA UDI | Class I | Active |
| Puritan | 25-806 2WC | EUDAMEDFDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3320-H | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-808 2PR | EUDAMEDFDA UDI | Class I | Active |
| Puritan PurFlock | 25-3306-U FDNA | FDA UDI | Class I | Active |
| Puritan | 25-806 1PD | EUDAMEDFDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3306-U BT | EUDAMEDFDA UDI | Class I | Active |
| Puritan PurFlock Ultra | 25-3317-U | EUDAMEDFDA UDI | Class I | Active |
| Puritan Cap-Shure | 25-807 1PC EC | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-1607 1PF SC | EUDAMEDFDA UDI | Class I | Active |
| Puritan UniTranz-RT | UT-361 | FDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3317-H | EUDAMEDFDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3406-H | EUDAMEDFDA UDI | Class I | Active |
| Puritan | LB-500 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 2WD | FDA UDI | Class I | Active |
| Puritan | MRSA-200 | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 2PC | EUDAMEDFDA UDI | Class I | Active |
| Puritan | 25-806 1WC 7.5 | EUDAMEDFDA UDI | Class I | Active |
| Puritan HydraFlock | 25-3806-H | EUDAMEDFDA UDI | Class I | Active |
| Puritan FAB-SWAB | 25-825 1WCS TT FABUSA | EUDAMEDFDA UDI | Class I | Active |
| CerfiSoft Foam Cytology Collection Swab | 25-2197 | FDA UDI | Class II | Active |
| Puritan PurFlock Ultra | 25-3316-U EMB 80 BT | FDA UDI | Class I | 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 |