Question 1

What types of medical devices does Smisson-Cartledge Biomedical, LLC manufacture?

Accepted Answer

Smisson-Cartledge Biomedical, LLC specialises in conduction blood/fluid warmers. These devices are designed to maintain the temperature of infused fluids during medical procedures, helping to prevent hypothermia in patients receiving intravenous treatments. Their primary product line includes systems like the ThermaCor 1200 Infusion System, which is intended for clinical use.

Question 2

Where is Smisson-Cartledge Biomedical, LLC based?

Accepted Answer

The company is headquartered in the United States. This location is relevant for regulatory oversight, as their devices are authorised under U.S. regulatory frameworks like the FDA’s 510(k) and UDI programs.

Question 3

Which regulatory registries or databases list Smisson-Cartledge Biomedical’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries track authorised medical devices under U.S. regulations, ensuring transparency and compliance for healthcare providers and regulators.

Question 4

How are Smisson-Cartledge Biomedical’s devices classified under FDA regulations?

Accepted Answer

The company’s conduction blood/fluid warmers fall under Class II classification by the FDA. This classification is assigned based on the device’s intended use and risk level, requiring special controls beyond general controls to ensure safety and effectiveness. The ThermaCor 1200 Infusion System, for example, undergoes the 510(k) process to demonstrate compliance with these controls before being authorised.

Device	Model / Reference	Registries	Class	Status
ThermaCor 1200 Infusion System	MR-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	FS-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	TSS-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	SP-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	RCE-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	RCB-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	TIS-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	DC-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	TH-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	TD-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	PTC-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	DNC-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	CG-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	PNC-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	EL-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	PL-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	DL-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	RCAU-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	MH-1200	FDA UDI	Class II	Active
ThermaCor 1200 Infusion System	RC-1200	FDA UDI	Class II	Active
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System	K202461	FDA 510(k)	Class II	Active
Smisson-Cartledge Thermal Infusion System, Model Tis-1200	K052055	FDA 510(k)	Class II	Active

Date	Recall No.	Class	Status	Reason
Feb 18, 2021	Z-1259-2021	—	terminated	Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Feb 18, 2021	Z-1258-2021	—	terminated	Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Feb 18, 2021	Z-1260-2021	—	terminated	Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

Smisson-Cartledge Biomedical, LLC

What Smisson-Cartledge Biomedical, LLC makes

Frequently asked questions

Information

Catalogue (22)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Recalls (3)