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Sign in to claim this brandSummit Medical Products, Inc.
US
Last updated May 27, 2026
What Summit Medical Products, Inc. makes
Summit Medical Products manufactures single-use medical devices for infusion therapy, anaesthesia, and surgical procedures, including electric infusion pump administration sets, ambulatory non-insulin infusion pumps, and parenteral/enteral solution bags. Their portfolio also covers anaesthesia conduction catheters, manual scalpel blades, subcutaneous tunnellers, endotracheal tube introducers, and sterile enteral feeding/medication connectors.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These devices are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with US medical device regulations. The manufacturer is based in the United States.
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 Summit Medical Products, Inc. manufacture?
Summit Medical Products, Inc. specializes in single-use medical devices primarily for infusion therapy, anaesthesia, and surgical applications. Their product range includes electric infusion pump administration sets, ambulatory non-insulin infusion pumps, parenteral/enteral solution bags, anaesthesia conduction catheters, manual scalpel blades, subcutaneous tunnellers, endotracheal tube introducers, and sterile enteral feeding/medication connectors. These devices are designed for use in clinical settings where precision, sterility, and ease of use are critical.
Where is Summit Medical Products, Inc. based?
Summit Medical Products, Inc. is headquartered in the United States. Being based in the US aligns their operations with FDA regulatory requirements, ensuring their devices comply with domestic medical device standards and registries.
Which regulatory registries list Summit Medical Products, Inc.’s devices?
Summit Medical Products, Inc.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These registries track devices that have undergone the necessary premarket submissions and compliance checks required by the FDA, ensuring transparency and traceability for healthcare providers and regulators.
How are Summit Medical Products, Inc.’s devices classified under FDA regulations?
Summit Medical Products, Inc.’s devices fall into Class I and Class II categories under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it.
Why are some of Summit Medical Products, Inc.’s devices listed in the FDA’s 510(k) registry?
Devices listed in the FDA’s 510(k) registry have undergone a premarket notification process, where the manufacturer demonstrates that their device is substantially equivalent to a legally marketed predicate device. This means Summit Medical Products, Inc. has provided evidence that their infusion pumps, administration sets, or other devices perform similarly to an already-authorized product in terms of safety and effectiveness, allowing them to enter the market without requiring a full premarket approval (PMA) process.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ambitmpi.com
- —
- —
- [email protected]
- Phone
- 8013521888
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 831704841
Catalogue (82)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MediBag | 220121 | FDA UDI | Class II | Active |
| ambIT | 220569 | FDA UDI | Class II | Active |
| ambIT | 220561 | FDA UDI | Class II | Active |
| ambIT | 220517Y | FDA UDI | Class II | Active |
| MediBag | 220533 | FDA UDI | Class II | Active |
| ambIT | 220404 | FDA UDI | Class II | Active |
| ambIT | 220462 | FDA UDI | Class II | Active |
| ambIT | 220140Y | FDA UDI | Class II | Active |
| Uni-Flo | 220491 | FDA UDI | Class II | Active |
| ambIT | 220140 | FDA UDI | Class II | Active |
| ambIT | 220468 | FDA UDI | Class II | Active |
| ambIT | 220316 | FDA UDI | Class II | Active |
| ambIT | 220466 | FDA UDI | Class II | Active |
| ambIT | 220568 | FDA UDI | Class II | Active |
| ambIT | 220539 | FDA UDI | Class II | Active |
| ambIT | 220575 | FDA UDI | Class II | Active |
| ambIT | 220266Y | FDA UDI | Class II | Active |
| ambIT | 220266mil | FDA UDI | Class II | Active |
| Uni-Flo | 220490 | FDA UDI | Class II | Active |
| ambIT | 220501 | FDA UDI | Class II | Active |
| ambIT | 220418 | FDA UDI | Class II | Active |
| ambIT | 220546 | FDA UDI | Class II | Active |
| ambIT | 220501Y | FDA UDI | Class II | Active |
| ambIT | 220470 | FDA UDI | Class II | Active |
| ambIT | 220534 | FDA UDI | Class II | Active |
| ambIT | 220517 | FDA UDI | Class II | Active |
| ambIT | 220405 | FDA UDI | Class II | Active |
| MediBag | 220582 | FDA UDI | Class II | Active |
| Ambit Introducer, Ambit Needle, Ambit Sheath | K102460 | FDA 510(k) | Class II | Active |
| Ambit Tunneler | K110814 | FDA 510(k) | Class II | Active |
| ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | K162165 | FDA 510(k) | Class II | Active |
| Direct Antibiotic Infusion Kit | K113043 | FDA 510(k) | Class II | Active |
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