MEDCARE TRACHEOSTOMY CARE TRAY
Device Facts
| Record ID | K961167 |
|---|---|
| Device Name | MEDCARE TRACHEOSTOMY CARE TRAY |
| Applicant | Medcare Medical Group, Inc. |
| Product Code | LRQ · SU |
| Decision Date | Jul 2, 1996 |
| Decision | SESK |
| Submission Type | Traditional |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Intended Use
The Medicare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
Device Story
Tracheostomy Care Tray provides essential components for tracheostomy tube maintenance and stoma site care; includes supplies for wound cleaning, suctioning, and cannula replacement. Sterile, single-use, disposable kit; used in clinical settings by healthcare providers. Facilitates standardized care procedures; ensures availability of necessary tools for hygiene and site maintenance; supports patient safety by reducing infection risk through single-use components.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Sterile, single-use, disposable kit containing various components for tracheostomy care. Materials and design are functionally identical to predicate tracheostomy care trays. No energy source or software components.
Indications for Use
Indicated for patients requiring tracheostomy care, including stoma wound care, suctioning (oral, nasal, pharyngeal, tracheal), and cleaning or replacement of tracheostomy tubes or inner cannulas.
Regulatory Classification
Identification
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Predicate Devices
- Busse Hospital Disposables Tracheostomy Care Trays
- Concord/Portex Tracheostomy Care Trays
Related Devices
- K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT · Opportunity, Inc. · Sep 16, 1997
- K023276 — AMSINO TRACHEOSTOMY CARE TRAY · Amsino International, Inc. · Dec 9, 2002
- K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA · Regulatory and Marketing Services, Inc. · Mar 24, 2011
- K964056 — RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE · Rusch Intl. · Oct 10, 1997
- K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA · Mallinckrodt Medical · Jun 16, 2005
