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Sign in to claim this brandSpsmedical Supply Corp.
US
Last updated May 23, 2026
What Spsmedical Supply Corp. makes
Spsmedical Supply Corp. manufactures sterilization indicators and packaging for single-use medical devices, including chemical and biological markers for steam, ethylene oxide (EO), and dry heat processes. Their products include mail-in systems for biological indicators, self-contained steam biological indicators, and chemical vapor/EO indicator strips. They also supply disposable sterilization wraps and culture kits for monitoring sterilization efficacy.
Their portfolio is regulated under FDA Class II devices and includes entries in the FDA’s 510(k) and UDI registries. The company 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 Spsmedical Supply Corp. manufacture?
Spsmedical Supply Corp. specializes in sterilization-related products, including chemical and biological indicators for monitoring sterilization processes. Their devices track the effectiveness of sterilization methods like steam, ethylene oxide (EO), and dry heat. They also produce single-use sterilization packaging, such as disposable wraps, and biological monitoring services like mail-in systems and culture kits. These products ensure medical devices are safely sterilized before use.
Where is Spsmedical Supply Corp. based, and how does that affect its regulatory oversight?
Spsmedical Supply Corp. is based in the United States, which means its devices fall under FDA jurisdiction. Since the company’s products are classified as Class II devices, they are subject to FDA’s 510(k) premarket notification process and must comply with UDI (Unique Device Identifier) requirements. The FDA registers these devices in its 510(k) and UDI databases to track compliance and market performance.
Which regulatory registries list Spsmedical Supply Corp.’s devices, and why?
Spsmedical Supply Corp.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process ensures that each device meets FDA safety and effectiveness standards before entering the market, while the UDI system provides a unique identifier for tracking devices throughout their lifecycle. These registries help regulators and healthcare providers verify compliance and traceability of sterilization-related products.
How are Spsmedical Supply Corp.’s devices classified by the FDA, and what does that mean for users?
Spsmedical Supply Corp.’s devices are classified as FDA Class II, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification requires manufacturers to submit a 510(k) premarket submission to demonstrate their devices meet regulatory requirements. For users, this classification indicates that these sterilization indicators and packaging have undergone evaluation to help ensure reliable performance in medical sterilization processes.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (124)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dual Dual Dot Label | DDOT-2000 | FDA UDI | Class II | Active |
| Sporview Self-Contained Steam Bi | SCS010 | FDA UDI | Class II | Active |
| Sporview Steam Bi Test Pack-25 Cntrls | SBT-025 | FDA UDI | Class II | Active |
| Dry heat Chemical Indicator label | DSL-100 | FDA UDI | Class II | Active |
| Latex Lead Free Steam Tape | LF2-036 | FDA UDI | Class II | Unknown |
| Steamplus Tray Record Card | TRC-050-IU | FDA UDI | Class II | Active |
| Steam Indicator Label | STL-250 | FDA UDI | Class II | Active |
| Dual Monitor Strip | DMS-250 | FDA UDI | Class II | Active |
| Steam Verification Test Kit | SVK-012 | FDA UDI | Class II | Active |
| Dual Record Card | DLC-058 | FDA UDI | Class II | Active |
| ConFirm In-Office Biological Monitoring System | C10SKBASIC | FDA UDI | Class II | Active |
| Sporview Self-Contained Starter Kit | SK-116 | FDA UDI | Class II | Active |
| Blue Steam Tape | BT-048 | FDA UDI | Class II | Unknown |
| Dual Dot Label | DDL-010 | FDA UDI | Class II | Active |
| Patient Record Card | PRC-250 | FDA UDI | Class II | Active |
| Eo Gas Indicator Strip | GIS-250 | FDA UDI | Class II | Active |
| Steam Indicator Strip | SIS-100 | FDA UDI | Class II | Active |
| SporView SELF-CONTAINED EO GAS BI | SCG-100 | FDA UDI | Class II | Unknown |
| Sporview Steam Sterilizer Monitoring Starter Kit | SK-115 | FDA UDI | Class II | Active |
| Sporview Steam Bi Test Pack-5 Cntrls | SBT-255 | FDA UDI | Class II | Active |
| Gas Plasma Label, Red | GPL-2000R | FDA UDI | Class II | Active |
| Passport Plus Mail-In System | PP-052 | FDA UDI | Class II | Active |
| Steamplus Sterilization Integrator | SSI-250 | FDA UDI | Class II | Active |
| Sporview Self-Contained Steam Bi | SCS-106 | FDA UDI | Class II | Active |
| SPS Medical | ESW-8920 | FDA UDI | Class II | Active |
| Sporview Plus Self-Contained Starter Kit | SK-116-P | FDA UDI | Class II | Active |
| AirView II BOWIE-DICK TEST PACK | MBD030 | FDA UDI | Class II | Active |
| Sporview Self-Contained Steam Bi | SCS-100 | FDA UDI | Class II | Active |
| Sterilization Chemical Indicator Labels | SGL-1000 | FDA UDI | Class II | Active |
| SPS Medical | SK-037 | FDA UDI | Class II | Active |
| Passport Mail-In System | PS-052 | FDA UDI | Class II | Active |
| Gas Plasma Dots | PIP-P01 | FDA UDI | Class II | Active |
| Chemical Vapor Tape | VT-048 | FDA UDI | Class II | Unknown |
| Blue Steam Dot | SBD-038 | FDA UDI | Class II | Active |
| Airview Bowie-Dick Test Pack | SBD-030 | FDA UDI | Class II | Active |
| Sporview 10 Hour Steam Scbi | SVT-050 | FDA UDI | Class II | Active |
| SPS Medical Supply Co | EMP-104 | FDA UDI | Class II | Unknown |
| SPS Medical Supply Co | SSI-1000E | FDA UDI | Class II | Unknown |
| Sporview Self-Contained Steam Bi | SCS-025 | FDA UDI | Class II | Active |
| Steam Indicator Label | SIL-1000 | FDA UDI | Class II | Active |
| Sporview Self-Contained Steam Bi | SCP-025 | FDA UDI | Class II | Active |
| Steamplus Tray Record Card | TRC-050 | FDA UDI | Class II | Active |
| Steam Indictr Strip | SIS-250 | FDA UDI | Class II | Active |
| Dual Record Card | DLC-250 | FDA UDI | Class II | Active |
| Dual Expiration Label | DEL-010 | FDA UDI | Class II | Active |
| Dual Dual Load Card | SCL02 | FDA UDI | Class II | Active |
| Airview Bowie Dick; Test Pack, Indicator Sheets | K130211 | FDA 510(k) | Class II | Active |
| Sporview Steam Self-Contained Biological Indicator | K070595 | FDA 510(k) | Class II | Active |
| C-Vapor Sterilization Indicator, Chemical Vapor | K890757 | FDA 510(k) | Class II | Active |
| Spsmedical Sporview Steam Bi | K111515 | FDA 510(k) | Class II | Active |
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