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US
Last updated May 23, 2026
What GERI-GENTLE CORPORATION makes
Geriatric Gentle Corporation manufactures single-use medical devices for patient care, including indwelling urethral drainage catheters like Foley catheters, non-powdered vinyl and nitrile examination gloves, and catheterization kits. Their portfolio also includes general-purpose syringes, safety-needle medication cartridges, intravenous administration sets, and heat/moisture exchangers for respiratory support.
The company’s devices are regulated under the FDA’s UDI system, with products classified as either Class I or Class II. These items are intended for use in clinical and home healthcare settings, adhering to U.S. medical device compliance requirements.
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 Geri-Gentle Corporation manufacture?
Geri-Gentle Corporation produces single-use medical devices primarily for patient care, including indwelling urethral drainage catheters like Foley catheters, non-powdered vinyl and nitrile examination gloves, and catheterization kits. Their portfolio also covers general-purpose syringes, safety-needle medication cartridges, intravenous administration sets, and heat/moisture exchangers for respiratory support. These devices are designed for use in clinical and home healthcare settings.
Where is Geri-Gentle Corporation based?
Geri-Gentle Corporation is based in the United States. The company’s devices are developed and manufactured in compliance with U.S. regulatory standards, ensuring they meet the requirements for medical devices in the country.
Which regulatory registries list Geri-Gentle Corporation’s devices?
Geri-Gentle Corporation’s devices are listed under the FDA’s Unique Device Identification (UDI) system. This system is used to track and identify medical devices throughout their distribution lifecycle, ensuring traceability and compliance with U.S. regulatory requirements.
How are Geri-Gentle Corporation’s devices classified under U.S. regulations?
Geri-Gentle Corporation’s devices are classified as either Class I or Class II under U.S. medical device regulations. Class I devices generally pose minimal risk and are 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 risks, and benefits.
What is the reasoning behind the classification of Geri-Gentle Corporation’s Foley catheters?
Foley catheters produced by Geri-Gentle Corporation are classified as Class II devices. This classification is due to their role in managing urinary drainage, which carries moderate risks such as infection or tissue damage if not used correctly. Class II classification requires compliance with specific performance standards to mitigate these risks, ensuring patient safety and device effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 361663839
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Foley Catheter | 21-035 | FDA UDI | Class II | Active |
| Gloves | 12-309 | FDA UDI | Class I | Active |
| Gloves | 12097 | FDA UDI | Class I | Active |
| IV Extension Set | 11762 | FDA UDI | Class II | Active |
| Foley Catheter | 21-045 | FDA UDI | Class II | Active |
| NEEDLES 23x1 | 11-231 | FDA UDI | Class II | Active |
| Gloves | 12890 | FDA UDI | Class I | Active |
| Syringe 3ml | 11-300 | FDA UDI | Class II | Active |
| Syringes Safety | 11467 | FDA UDI | Class II | Active |
| Gloves | 12892 | FDA UDI | Class I | Active |
| Foley Catheter | 21-030 | FDA UDI | Class II | Active |
| Foley Catheter | 21-050 | FDA UDI | Class II | Active |
| Sharps Collector 5QT | 11138 | FDA UDI | Class II | Active |
| Foley Catheter | 21151 | FDA UDI | Class II | Active |
| NEEDLES 25x5/8 | 11-2558 | FDA UDI | Class II | Active |
| Syringes Safety | 11466 | FDA UDI | Class II | Active |
| Geri-Gentle | 1221 | FDA UDI | Class II | Active |
| Syringes Safety | 11466 | FDA UDI | Class II | Active |
| NEEDLES 25x1 | 11-251 | FDA UDI | Class II | Active |
| Gloves | 12895 | FDA UDI | Class I | Active |
| Foley Catheter | 21044 | FDA UDI | Class II | Active |
| IV Administration Set Needless | 11222 | FDA UDI | Class II | Active |
| Geri-Gentle | 21-565 | FDA UDI | Class II | Active |
| Geri-Gentle | 21-486 | FDA UDI | Class II | Active |
| IV Administration Set | 11221 | FDA UDI | Class II | Active |
| Lancets Safety | 25-457 | FDA UDI | Class II | Active |
| Geri-Gentle | 21-515 | FDA UDI | Class II | Active |
| Gloves | 12290 | FDA UDI | Class I | Active |
| Gloves | 12291 | FDA UDI | Class I | Active |
| Foley Catheter | 21-025 | FDA UDI | Class II | Active |
| Foley Catheter | 21-060 | FDA UDI | Class II | Active |
| HMEF w/ Flextube | 19-HMEF100 | FDA UDI | Class II | Active |
| Geri-Gentle | 21-490 | FDA UDI | Class II | Active |
| Pen Needle | 11-305 | FDA UDI | Class II | Active |
| SYRINGE RETRACT U100 1cc 29x.5 | 11-444 | FDA UDI | Class II | Active |
| Foley Catheter | 21-020 | FDA UDI | Class II | Active |
| Gloves | 12893 | FDA UDI | Class I | Active |
| Foley Catheter | 21-080 | FDA UDI | Class II | Active |
| Sterile Drape | 13-055 | FDA UDI | Class II | Active |
| Oxygen Concentrator | 19-5000 | FDA UDI | Class II | Active |
| Prefilled Syrings | 11-1010 | FDA UDI | Class II | Active |
| Foley Catheter | 21-065 | FDA UDI | Class II | Active |
| Foley Catheter | 21-061 | FDA UDI | Class II | Active |
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