U.S. FDA Medical Device Noninvasive Tubing Requirements
FDA Medical Device Definition: A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
FDA Noninvasive Tubing Label Requirements and Exceptions
FDA Noninvasive Tubing Import Information
FDA Noninvasive Tubing Detentions (Noninvasive Tubing Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Noninvasive Tubing Manufacturers (Noninvasive Tubing Suppliers)
- Noninvasive Tubing Distributors
- Noninvasive Tubing Processors
- Noninvasive Tubing Repackers
- Noninvasive Tubing Relabelers
- Noninvasive Tubing Exporters
- Noninvasive Tubing Importers
For more information about Noninvasive Tubing Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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