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(a) Identification. A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:
(1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged;
(2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries;
(3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches;
(4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient;
(5) The distance between components of the side rail (i.e., slats, spindles, and corner posts) shall not be greater than 2
3/8 inches (6 centimeters) apart at any point;
(6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented;
(7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4-72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and
(8) Each device must have the following label(s) affixed:
(i) Adequate instructions for users to care for, maintain, and clean the crib; and
(ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height:
WARNING: Never leave a child unsupervised when the moveable side is open or not secured.
[81 FR 91737, Dec. 19, 2016]
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