BLOOM43
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Basic Information
- Brand Name
- BLOOM43
- Primary DI
- 05065023510009
- Version / Model
- B4301
- Company Name
- PLEXAA LTD
- Labeler DUNS
- 224679195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-13
- Public Version
- 1
- Public Version Date
- 2025-10-21
- Public Version Status
- New
- Public Device Record Key
- 6c225f12-f313-4156-b88c-80e16f4b11a0
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62194 | Electric pad localized-body heating system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065023510009 | GS1 |