Indicator, Physical/Chemical, Storage Temperature

OCI · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2800

Classification

FDA Product Code: OCI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.2800
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown