# Datex-Ohmeda, Inc. (specification developer, Waukesha, WI): 3 new FDA device listings, incl. system, monitoring, perinatal

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Datex-Ohmeda, Inc. |
| Owner / operator | GE HealthCare Technologies Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Waukesha, WI, US |
| New listings | 3 |
| Devices | System, Monitoring, Perinatal; Incubator, Neonatal; Warmer, Infant Radiant |
| Product codes | HGM, FMZ, FMT |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology, General Hospital |
| Brand names | Novii+ Pod; Novii+ Interface; Novii+ Wireless Patch System; Giraffe Incubator Carestation CS1; Giraffe Omnibed Carestation CS1 |
| First new listing | 2026-09-09 |
| Latest new listing | 2026-09-09 |
| FDA registration number | 3036470679 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.