BLOOM43

Primary DI
05065023510009
Brand
BLOOM43
Company
PLEXAA LTD
Model
B4301
Device description
BLOOM43 is a wearable medical device consisting of a preconditioning unit connected to a battery via a cable. The preconditioning unit integrates a user interface and a temperature-controlled heating element. Designed for preoperative use, BLOOM43 delivers supraphysiological preconditioning to the skin through the application of topical heat, which temporarily improves blood flow circulation. The battery can be securely attached to clothing or carried in a pocket for convenience. The preconditioning unit is intended to be placed within a bra, positioned against the breast skin (ideally centered over the nipple-areola complex), and worn for approximately 3 hours. It operates in a series of 30-minute active heating cycles within the range of 40°C (104°F) to 45.5°C (113.9°F), with an approximate skin temperature of 40°C (104°F) to 44°C (111.2°F), alternating with nonactive heating periods.
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05065023510009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065023510009050650235100095065023510009

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Regulatory Flags#

DUNS number
224679195
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Company table
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