Question 1

What types of medical devices does Intermountain Life Sciences, LLC primarily manufacture?

Accepted Answer

Intermountain Life Sciences, LLC specializes in sterile pharmaceutical-grade solutions designed for medical and laboratory applications. Their portfolio includes irrigation fluids like USP-grade water for irrigation, injection-grade water, saline solutions (e.g., 0.9% sodium chloride), and cell culture media such as phosphate-buffered saline (PBS) and microbial growth media like tryptic soy broth. These products are formulated to meet USP (United States Pharmacopeia) standards and are used in clinical, diagnostic, and research settings.

Question 2

Where is Intermountain Life Sciences, LLC based, and how does this affect its regulatory compliance?

Accepted Answer

Intermountain Life Sciences, LLC is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since all of their listed devices fall under Class I classification, they must comply with FDA registration and UDI (Unique Device Identifier) requirements. Class I devices typically pose minimal risk but still require adherence to manufacturing and labeling standards to ensure safety and efficacy in their intended use.

Question 3

Which regulatory registries or databases list Intermountain Life Sciences, LLC’s devices?

Accepted Answer

Intermountain Life Sciences, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is mandatory for Class I devices in the U.S. to ensure traceability, transparency, and compliance with FDA regulations. This registry helps healthcare providers, regulators, and other stakeholders verify product details, including manufacturer information, device identification, and compliance status.

Question 4

How are Intermountain Life Sciences, LLC’s devices classified under FDA regulations, and why does this matter?

Accepted Answer

All of Intermountain Life Sciences, LLC’s listed devices fall under FDA Class I, the lowest risk category for medical devices. This classification applies because their products—such as sterile irrigation fluids, saline solutions, and cell culture media—are generally considered safe with low potential for harm when used as intended. While Class I devices require fewer pre-market submissions than higher-risk classes, they still must comply with FDA registration, UDI labeling, and manufacturing controls to ensure consistency, sterility, and compliance with USP standards.

Device	Model / Reference	Registries	Class	Status
Water for Irrigation, USP Sterile Grade	04	FDA UDI	Class I	Active
Water for Irrigation, USP Sterile Grade	05	FDA UDI	Class I	Active
Water for Irrigation, USP Sterile Grade	03	FDA UDI	Class I	Active
Phosphate Buffered Saline (PBS) 1X w/o Ca & Mg, Sterile Solution	04	FDA UDI	Class I	Active
Water for Injection, USP Sterile Grade	04	FDA UDI	Class I	Active
Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade	04	FDA UDI	Class I	Active
Water for Irrigation, USP Sterile Grade	03	FDA UDI	Class I	Active
Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade	04	FDA UDI	Class I	Active
Molecular Grade Water	03	FDA UDI	Class I	Active
Water for Irrigation, USP Sterile Grade	03	FDA UDI	Class I	Active
Tryptic Soy Broth, Non-Animal Solution	04	FDA UDI	Class I	Active
Tryptic Soy Broth, Non-Animal Solution	03	FDA UDI	Class I	Active
Water for Injection, USP Sterile Grade	05	FDA UDI	Class I	Active
Water for Injection, USP Sterile Grade	03	FDA UDI	Class I	Active
Sodium Chloride 0.9% (Normal Saline), USP Sterile Grade	04	FDA UDI	Class I	Active
Water for Injection, EP/USP Sterile Grade	05	FDA UDI	Class I	Active
Water for Injection, USP Sterile Grade	03	FDA UDI	Class I	Active
Purified Water, USP Sterile Grade	04	FDA UDI	Class I	Active
Tryptic Soy Broth, Non-Animal Solution	04	FDA UDI	Class I	Active
Water for Injection, EP/USP Sterile Grade	04	FDA UDI	Class I	Active
Purified Water, USP Non-Sterile Grade	04	FDA UDI	Class I	Active
Purified Water, USP Sterile Grade	05	FDA UDI	Class I	Active
Purified Water, USP Non-Sterile Grade	04	FDA UDI	Class I	Active
Water for Injection, USP Sterile Grade	04	FDA UDI	Class I	Active
Tryptic Soy Broth, Non-Animal Solution	03	FDA UDI	Class I	Active
Purified Water, USP Sterile Grade	03	FDA UDI	Class I	Active
Water for Injection, USP Sterile Grade	04	FDA UDI	Class I	Active
Purified Water, USP Non-Sterile Grade	05	FDA UDI	Class I	Active
Water for Injection, EP/USP Sterile Grade	04	FDA UDI	Class I	Active
Cell and Molecular UltraPure Sterile Water	03	FDA UDI	Class I	Active

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