FDA UDI
In Commercial Distribution
🇺🇸 United States
AVACEN
DI: 00862800000372
·
Model: AVACEN HOME XL 3-YEAR
·
AVACEN MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AVACEN
- Primary DI
- 00862800000372
- Version / Model
- AVACEN HOME XL 3-YEAR
- Company Name
- AVACEN MEDICAL, INC
- Labeler DUNS
- 832744754
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-10
- Public Version
- 1
- Public Version Date
- 2023-03-20
- Public Version Status
- New
- Public Device Record Key
- 7a45571f-fc1e-42a2-8945-9c09dc1f2f96
Device Description
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 | 00862800000372 | GS1 |
Customer Contacts
- Phone
- 888-428-2236
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133981 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1600 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 140 Degrees Fahrenheit