FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MiBo Heating Pad Mask
DI: 00869086000317
·
Model: 3936275
·
PAIN POINT MEDICAL SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MiBo Heating Pad Mask
- Primary DI
- 00869086000317
- Version / Model
- 3936275
- Company Name
- PAIN POINT MEDICAL SYSTEMS INC.
- Labeler DUNS
- 084045250
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-28
- Public Version
- 3
- Public Version Date
- 2026-02-23
- Public Version Status
- Update
- Public Device Record Key
- 777d5f6c-9983-4708-b069-5487821ba2bf
- Distribution End Date
- 2026-02-21
Device Description
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 11989 | External electric-heating core temperature regulation system pad | An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869086000317 | GS1 |
Customer Contacts
- Phone
- 2145078091
- [email protected]