Source: FDA Establishment Registration — Bunnell Incorporated

Summary

FDA's device establishment registration and listing record for the Life Pulse ventilator, retrieved 2026-08-11. It exists to answer one question the company's own website could only assert: whether Bunnell actually manufactures in Utah, or merely sells hardware built elsewhere. FDA registers the physical establishment, so the record is independent of the company's marketing.

Class A source: re-derivable by re-running the query above, or by searching FDA's registration database for FEI 3032745446.

Useful Claims

• Owner/operator: BUNNELL INCORPORATED. Establishment name "Cutler Campus."
• Establishment type includes "Manufacture Medical Device" (also "Complaint File Establishment per 21 CFR 820.198"). This is the load-bearing field: FDA classifies the site as a manufacturing establishment, not solely a distributor or complaint-handling office.
• Registration number / FEI: 3032745446, status code 1, registration year 2026 — an active registration at retrieval, not a lapsed historical record.
• Address: 330 North Cutler Dr, North Salt Lake, UT 84054, matching the company's published address and distinct from the 1988 PMA record's 436 Lawndale Dr., Salt Lake City.
• Listed product code: LSZ, the same high-frequency ventilator code as the Life Pulse PMA.

Verbatim

Structured API fields rather than prose; the values above are quoted from the response's owner_operator.firm_name, establishment_type, registration_number, fei_number, status_code, reg_expiry_date_year, name, address, and products[].product_code. No excerpt is carried because the document is a JSON record, re-derivable by identifier.

Reliability Notes

Primary tier: FDA's own registration data, at FDA's own host, keyed to a durable establishment identifier.

What it establishes is narrower than it looks, and worth stating precisely. A registered manufacturing establishment at a Utah address means FDA recognizes device manufacturing there. It does not establish what share of the device is built on site versus assembled from outsourced subassemblies, nor headcount, nor output. It is sufficient to retire the weaker question — whether the company is a Utah sales office for hardware made elsewhere — and insufficient to characterize the depth of the manufacturing.

The same openFDA disclaimer applies as on the PMA record: openFDA states its extracts are unvalidated and should not be relied on for decisions regarding medical care. For regulatory-critical use, confirm against FDA's establishment registration database directly.

Related Pages

• Bunnell Incorporated
• Source: FDA PMA Record — Bunnell Life Pulse