Device
BP37 Infant Temperature Maintenance Kit - Controller
Manufacturer
ADVANCED HEALTHCARE TECHNOLOGY LIMITED
ADVANCED HEALTHCARE TECHNOLOGY LIMITED
Model: BP37 Controller
Catalog: BP37-002
DI: 05060950290055
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
BP37 Infant Temperature Maintenance Kit - Controller
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3ab2ffb9-a451-4fff-ac96-0ab8fb415b2a
Distribution Status:
In Commercial Distribution
DUNS Number:
346032980
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05060950290055
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37329
Name: Electric pad whole-body heating system
Definition:
An 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.
FDA Product Codes
IRT
Pad, Heating, Powered