Chrysalis Intelligence · Product Codes · FMT

FMT · Warmer, Infant Radiant

General Hospital · 6 clearances · 4 unique sponsors

Device class
Class II
Regulation 880.5130
Total clearances
6
2020-01-21 → 2025-01-17
Last 12 months
0
Unique sponsors
4
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5130
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Deroyal Industries, Inc. 2 0 2020-04-02
Draeger Medical Systems, Inc. 2 0 2025-01-17
Datex Ohmeda, Inc. 1 0 2022-03-02
GE Healthcare 1 0 2021-02-12
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1372 HCPCS Immersion external heater for nebulizer ✓ CMS-verified description High Infant radiant warmer, neonatal equipment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-01-17 K243606 Draeger Medical Systems, Inc. Babyroo TN300
2023-05-30 K230278 Draeger Medical Systems, Inc. Babyroo TN300
2022-03-02 K213551 Datex Ohmeda, Inc. Giraffe Omnibed Carestation CS1
2021-02-12 K201628 GE Healthcare Panda iRes Warmer, Giraffe Warmer
2020-04-02 K200319 Deroyal Industries, Inc. HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
2020-01-21 K191425 Deroyal Industries, Inc. Hydro-Temp Neonatal Skin Temperature Probe Cover