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Sign in to claim this brandAERO HEALTHCARE (US), LLC
US
Last updated May 23, 2026
What AERO HEALTHCARE (US), LLC makes
The company produces single-use cardiopulmonary resuscitation (CPR) masks designed for emergency resuscitation, as well as medicated first aid kits containing pre-packaged medical supplies. Their portfolio also includes a modular device called the Modulator, which appears to be a reusable component for medical applications, and a product named Surefill, likely intended for filling or dispensing medical solutions.
These devices are classified under FDA’s Class I and Class N categories, with listings maintained in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to U.S. regulatory requirements for medical devices.
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 Aero Healthcare (US), LLC primarily manufacture?
Aero Healthcare (US), LLC specializes in single-use cardiopulmonary resuscitation (CPR) masks, which are essential for emergency resuscitation. They also produce medicated first aid kits containing pre-packaged medical supplies. Additionally, the company offers a reusable modular device called the Modulator and a product named Surefill, which appears to be designed for filling or dispensing medical solutions. These devices cater to both emergency and general medical care scenarios.
Where is Aero Healthcare (US), LLC based, and how does this affect its regulatory compliance?
Aero Healthcare (US), LLC is based in the United States, meaning its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identification (UDI) system, they are subject to U.S. medical device regulations, which include classification, labeling, and post-market surveillance standards.
Which regulatory registries or databases list Aero Healthcare’s devices?
Aero Healthcare’s devices are included in the FDA’s Unique Device Identification (UDI) system, which is a centralized database for tracking medical devices in the U.S. This system helps ensure traceability, regulatory compliance, and transparency in the medical device supply chain. The UDI listing is required for devices classified under FDA categories like Class I and Class N.
How are Aero Healthcare’s devices classified under FDA regulations?
Aero Healthcare’s devices fall under FDA’s Class I and Class N classifications. Class I generally includes low-risk devices that pose minimal potential harm to users, such as some single-use CPR masks and first aid kits. Class N specifically refers to non-surgical devices that do not support or sustain human life, do not present a potential unreasonable risk of illness or injury, and are not intended as an accessory to a Class I device. These classifications determine the regulatory oversight and compliance requirements for each product.
What distinguishes Aero Healthcare’s CPR masks and first aid kits from other similar products?
Aero Healthcare’s CPR masks are designed as single-use devices, which reduces the risk of cross-contamination in emergency scenarios. Their medicated first aid kits include pre-packaged medical supplies, likely tailored for quick access in non-emergency situations. The company’s focus on disposable CPR masks and structured first aid kits aligns with FDA’s Class I classification, emphasizing safety and ease of use in critical or routine medical situations. The inclusion of reusable components like the Modulator also suggests versatility in their product portfolio.
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
- 008186174
Catalogue (292)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surefill | SF21B | FDA UDI | N | Active |
| Custom | AKPCS01-282 | FDA UDI | N | Active |
| Custom | AAED-PK1 | FDA UDI | N | Active |
| Aerokit | AK50A | FDA UDI | N | Active |
| Surefill | AKPBT01 | FDA UDI | N | Active |
| Custom | AK10NR-3229 | FDA UDI | N | Active |
| Surefill | AK10NR | FDA UDI | N | Active |
| Custom | SF25AT-2832 | FDA UDI | N | Active |
| Surefill | AK50AV | FDA UDI | N | Active |
| Custom | AK50EWN-2814 | FDA UDI | N | Active |
| Aerokit | AK25 | FDA UDI | N | Active |
| Custom | AKP01-3115 | FDA UDI | N | Active |
| Custom | AK10W-233 | FDA UDI | N | Active |
| Custom | AK75EWN-288 | FDA UDI | N | Active |
| Custom | SS10WM-1652 | FDA UDI | N | Active |
| Custom | AKBF10W-2814 | FDA UDI | N | Active |
| Custom | AK25T-279-01 | FDA UDI | N | Active |
| Surefill | SF50ANR | FDA UDI | N | Active |
| Cardiact™ | CA-PK3US | FDA UDI | N | Active |
| Custom | AKBF10W-2818 | FDA UDI | N | Active |
| Custom | AK25AW-2437 | FDA UDI | N | Active |
| Custom | SS10WM-2693 | FDA UDI | N | Active |
| Rapidstop | RSK502 | FDA UDI | N | Active |
| Aerokit | AK50B | FDA UDI | N | Active |
| Custom | AK75EWN-107 | FDA UDI | N | Active |
| Custom | AKB10W-235 | FDA UDI | N | Active |
| Custom | SF25AW-002 | FDA UDI | N | Active |
| Surescan | SS21A | FDA UDI | N | Active |
| Rapidstop | RSK500 | FDA UDI | N | Active |
| Custom | SS10WM-1947 | FDA UDI | N | Active |
| Surefill | AK25AT | FDA UDI | N | Active |
| Custom | AK25AW-235 | FDA UDI | N | Active |
| Custom | AK10T-279 | FDA UDI | N | Active |
| Custom | AK75EWN-236 | FDA UDI | N | Active |
| Surefill | AKPIC01 | FDA UDI | N | Active |
| Custom | AK10W-130 | FDA UDI | N | Active |
| Custom | AK25AT-108 | FDA UDI | N | Active |
| Custom | AK10W-288-01 | FDA UDI | N | Active |
| Custom | AKBF10W-3618 | FDA UDI | N | Active |
| Custom | AK25AW-108 | FDA UDI | N | Active |
| Custom | SF50AW-327 | FDA UDI | N | Active |
| Surefill | AK50EWN | FDA UDI | N | Active |
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