| FSC APPLICATION DATA | FDA: CLASS 1 MEDICAL DEVICE |
| GENERAL CHARACTERISTICS ITEM DESCRIPTION | DESIGN BY "THOMAS", DESIGNED TO SECURE ET TUBE IN PLACE AFTER INSERTION IN THE TREACHEA; SECURES IN PLACE WITH A QUICK-SET SCREW; NO TAPING, VELCRO STRAP; PLIABLE BITE BLOCK; DISPOSABLE-ONE TIME USE, SUGGESTED SHORT TERM USE 24 HOURS; STRAP IS FITTED AROUND PATIENT'S NECK, WITHOUT MOVING THE HEAD; ITEMS PACKAGED 4 BOXES TO A CASE, CONTAINING 25 EACH, UNIT ORDER EQUAL 100 |
| PART NAME ASSIGNED BY CONTROLLING AGENCY | HOLDER TUBE TRACHEAL THOMAS DESIGN TO HOLD ET TUBE IN PLACE 100S |
| MODEL NUMBER | 500 ETH-ADULT |
| RELATIONSHIP TO SIMILAR EQUIPMENT | SIMILAR TO MODEL 400ETH, WHICH IS CHILD SIZE |
| SPECIAL FEATURES | ERGONOMICALLY ENGINEERED TO MEET NEEDS OF PATIENT AND HEALTH CARE PROVIDERS; SET SCREW ALLOWS EASY ADJUSTMENTS AND REMOVAL OF HOLDER; VELCRO STRAP HOLDS SECURELY AND COMFORTABLY EVEN WHEN WET; OPEN CELL FOAM-PADDED BACKING ALLOWS PATIENT'S SKIN TO BREATHE; STRAP FITS AROUND NECK NOT IN PATIENT'S HAIR |