Puritan Medical Products Company, LLC
Guilford, ME, US
PURITAN MEDICAL PRODUCTS COMPANY LLC appears in FDA device records in Guilford, ME. FDA records list 8 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Puritan Medical Products Company, LLC between 2012 and 2025. The busiest year on record is 2012, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 3 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport System | QBD | Substantially Equivalent | |
| K162284 | Puritan Fecal Opti-Swab Collection and Transport System | JSM | Substantially Equivalent | |
| K160082 | Puritan Opti-Tranz Cary-Blair Collection and Transport System | JSM | Substantially Equivalent | |
| K142366 | Puritan OptiTranz Liquid Stuart Collection and Transport System | JSM | Substantially Equivalent | |
| K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | LIO | Substantially Equivalent | |
| K120846 | TRANSPORT CULTURE MEDIUM DEVICE | LIO | Substantially Equivalent | |
| K113249 | TRANSPORT CULTURE MEDIUM DEVICE | JSM | Substantially Equivalent | |
| K111681 | HISTOBRUSH | HHT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1216735 | 1216735 | PURITAN MEDICAL PRODUCTS COMPANY LLC | 31 School St, GUILFORD, ME 04443 US | 2026 | and 4 more, listed in full below |
| 3017206126 | 3017206126 | PURITAN MEDICAL PRODUCTS, LLC | 129 N MAIN STREET, Pittsfield, ME 04967 US | 2026 | |
| 3018490419 | 3018490419 | Puritan Medical Products Company, LLC | 206 SAS Drive, Pittsfield, ME 04967 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXGApplicator, Absorbent Tipped, Sterile
- KZICulture Media, Enriched
- JSMCulture Media, Non-Propagating Transport
- JSGCulture Media, Non-Selective And Non-Differential
- JSJCulture Media, Selective And Non-Differential
- FMADepressor, Tongue, Non-Surgical
- LIODevice, Specimen Collection
- QBDMicrobial Nucleic Acid Storage And Stabilization Device
- HHTSpatula, Cervical, Cytological
- ILHSplint, Hand, And Components
- JTWSystem, Transport, Aerobic
- FTYTape, Measuring, Rulers And Calipers
- JTXTransport Systems, Anaerobic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1391-2024 | HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. | 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. | Class II | Open, Classified | |
| Z-1278-2015 | Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient. | Shaft breaks so that adequate patient specimen sample cannot be obtained. | Class II | Terminated | |
| Z-0317-04 | MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No. 536053-009, Reference Gas, containing Oxygen 21% plus/minus 0.02% Absolute, and Nitrogen: Balance., ED cylinder size. The label shows Manufactured for: Medical Graphics Corporation, St. Paul, MN, as the responsible firm. | Oxygen component is out of specification | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain