FDA.reportPublic FDA data

BP37

Primary DI
05060950290055
Brand
BP37
Company
ADVANCED HEALTHCARE TECHNOLOGY LIMITED
Model
BP37 Controller
Catalog number
BP37-002
Device description
BP37 Infant Temperature Maintenance Kit - Controller
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060950290055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060950290055050609502900555060950290055

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of electrically-powered devices designed to heat a patient's whole body to compensate for the loss of normal body heat. The system includes a flat pad with electrical heating elements designed to be placed under or over the patient, and a control unit to regulate the heat; some types may be capable of monitoring the temperature at the patient’s body surface. The pad is available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). It is typically used in the operating room (OR), adult or neonatal intensive care unit (ICU), recovery units, or during neonatal transportation.

Regulatory Flags#

DUNS number
346032980
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060950290000BabyPodBabyPod 20BP20-0012026-04-27
05060950290017BabyPodBabyPod 2BP2-0012026-04-27
05060950290031BabyPodScanPodSPOD-0012026-04-27
05060950290062BP37Thermal Support MatrixBP37-0082026-04-27
05060950290086BabyPodNeoPodNPOD-0012026-04-27
05060950290161BP37Starter Pack BP37-001 2026-04-27
05060950290185BP37BP37 Controller-LSBP37-002-LS2026-04-27
05060950290291BP37Starter Pack -LSBP37-001-LS2026-04-27
05060950290338BabyPodNeoPod-AeroNPOD-001-AERO2026-04-27
05060950290345BabyPodBabyPod 2-AeroBP2-001-AERO2026-04-27
05060950290352BabyPodBabyPod 20-AeroBP20-001-AERO2026-04-27

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