Print-ready dossier — use your browser's print dialog to save as PDF.
1st Responder Kit (EPMK-1st Responder Kit)
Model 01425RD · Altitude Technologies Inc. · DI 00850018201469
LRR — First Aid Kit With Drug
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-05 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Altitude Technologies Inc.
- VAI 2018-08-24 Altitude Technologies, Inc. · 5 citations
- VAI 2015-08-13 Altitude Technologies, Inc. · 1 citations