(160 days)
The Medical Products, Inc. Temporte and Tempo II™ warming cabinets are design to store and warm I.V. fluid bags/bottles, irrigation solution bags/bottles, blankets, towels, etc. prior to their use.
Warning: The facility should contact the manufacturer of the products to be place inside the warming cabinet and obtain guidelines for exposing their product to temperatures other than those stated on the bags or bottles.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Tempo and Temp H20 warming cabinets) and does not contain the information requested in your prompt.
Specifically, the document states:
- It's a "substantially equivalent letter" correcting a previous one.
- It discusses regulatory details, classifications, and general controls provisions of the Act.
- It mentions the "Indications for Use" for the warming cabinets.
- It provides contact information for the FDA.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets).
Therefore, I cannot extract the requested information from this document.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).