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Sign in to claim this brandREPRO MED SYSTEMS, INC.
US
Last updated May 24, 2026
What REPRO MED SYSTEMS, INC. makes
Repro Med Systems, Inc. manufactures manual emergency airway clearance suction systems, subcutaneous infusion and injection port needles, and mechanical infusion pump administration sets. The company also produces reusable ambulatory non-insulin mechanical infusion pumps.
The company is based in the United States and maintains a portfolio of Class I and Class II medical devices. These products are listed in the FDA 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Repro Med Systems, Inc. manufacture?
Repro Med Systems, Inc. specializes in several key device categories. Their portfolio includes manual emergency airway clearance suction systems, such as the Res-Q-Vac, designed for urgent patient care. They also produce subcutaneous infusion and injection port needles, like the HIgH-Flo™ Needle Set, which are used for precise fluid administration. Additionally, the company manufactures mechanical infusion pump administration sets and reusable ambulatory non-insulin infusion pumps, ensuring compatibility with infusion therapy needs.
Where is Repro Med Systems, Inc. based, and what does that mean for its regulatory oversight?
Repro Med Systems, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The company’s products are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system, indicating they are subject to FDA regulatory requirements for medical devices in the U.S. market.
Which regulatory registries list devices manufactured by Repro Med Systems, Inc., and why is this important?
Devices from Repro Med Systems, Inc. are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. The 510(k) database tracks devices that claim substantial equivalence to legally marketed predecessors, while the UDI system ensures traceability and transparency in the supply chain. This visibility helps healthcare providers, regulators, and other stakeholders verify device compliance and safety.
How are the devices manufactured by Repro Med Systems, Inc. classified under FDA regulations?
Repro Med Systems, Inc. manufactures both Class I and Class II devices under FDA regulations. Class I devices generally pose the lowest risk and may be subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential harm, and regulatory history, ensuring appropriate oversight for patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rmsmedpro.com
- —
- —
- [email protected]
- Phone
- +1(845)610-5587
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 048403299
Catalogue (310)
Page 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Res-Q-Vac | P1F001AFN | FDA UDI | Class I | Active |
| Res-Q-Vac | FSP6002R | FDA UDI | Class I | Active |
| Res-Q-Vac | P1N1S108N | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | SUPER62612 | FDA UDI | Class II | Active |
| Res-Q-Vac | P1F1R110NE | FDA UDI | Class I | Active |
| Res-Q-Vac | R1F1S10LNV | FDA UDI | Class I | Active |
| Res-Q-Vac | P1N1S000NGE | FDA UDI | Class I | Active |
| Res-Q-Vac | P2N1B1AFS | FDA UDI | Class I | Active |
| Res-Q-Vac | R1F1R110N | FDA UDI | Class I | Active |
| Res-Q-Vac | R1N1R000N | FDA UDI | Class I | Active |
| Res-Q-Vac | P2F00181S | FDA UDI | Class I | Active |
| Res-Q-Vac | R1N001AFS | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1B1AFSLED | FDA UDI | Class I | Active |
| Res-Q-Vac | P2F2B1AFS | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | RMS22606 | FDA UDI | Class II | Active |
| Res-Q-Vac | P1N1S110S | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | RMS62604 | FDA UDI | Class II | Active |
| Res-Q-Vac | R1N1S110N | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1S1L4S | FDA UDI | Class I | Active |
| Res-Q-Vac | R1F001L8N | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1R000S | FDA UDI | Class I | Active |
| Res-Q-Vac | P2F2S000S | FDA UDI | Class I | Active |
| Koru | 348143 | FDA UDI | Class II | Active |
| Res-Q-Vac | P2F1B1AFSLED | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | SUPER42612 | FDA UDI | Class II | Active |
| Res-Q-Vac | P1F00181S | FDA UDI | Class I | Active |
| Res-Q-Vac | P1N00110NE | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1E110N | FDA UDI | Class I | Active |
| HIgH-Flo™, RMS Precision Flow Rate TubingTM | FEXT | FDA UDI | Class II | Active |
| Res-Q-Vac | P1N1S110NCC | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | RMS12612 | FDA UDI | Class II | Active |
| RMS Precision Flow Rate TubingTM | F1 | FDA UDI | Class II | Active |
| Res-Q-Vac | P1F1S1C1S | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1S181S | FDA UDI | Class I | Active |
| Res-Q-Vac | FSP6001R | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F00110N | FDA UDI | Class I | Active |
| Res-Q-Vac | PLAKVAC1R | FDA UDI | Class I | Unknown |
| Res-Q-Vac | P1F1B000SV | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | RMS22406 | FDA UDI | Class II | Active |
| Res-Q-Vac | P1F1S000NG | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1R110N | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | SUPER12612 | FDA UDI | Class II | Active |
| Res-Q-Vac | P1F002L4S | FDA UDI | Class I | Active |
| Res-Q-Vac | RIN00110NCC | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | SUPER62606 | FDA UDI | Class II | Active |
| Res-Q-Vac | R1F1B134S | FDA UDI | Class I | Active |
| Res-Q-Vac | P1F1E000S | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | RMS52612 | FDA UDI | Class II | Active |
| Res-Q-Vac | R1F1R104S | FDA UDI | Class I | Active |
| HIgH-Flo™ Needle Set | RMS62612 | FDA UDI | Class II | 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.
Repro Med Systems, Inc. has three FDA recall records initiated between March 10, 2016, and August 20, 2019, all of which are marked as terminated. The first recall, initiated on February 24, 2016, involved visual defects in the manufacturing seal of a specific tubing lot and a related bag combo part, while the second and third records cited mislabeled needle lengths as the reason for recall initiation.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 20, 2019 | Z-0051-2020 | — | terminated | Mislabeled needle lengths |
| Mar 10, 2016 | Z-0318-2018 | — | terminated | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification. |
| Mar 10, 2016 | Z-0317-2018 | — | terminated | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification. |