FDA UDI
In Commercial Distribution
🇺🇸 United States
AVACEN
DI: 00862800000334
·
Model: 25-pack Mitts
·
AVACEN MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AVACEN
- Primary DI
- 00862800000334
- Version / Model
- 25-pack Mitts
- Company Name
- AVACEN MEDICAL, INC
- Labeler DUNS
- 832744754
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-19
- Public Version
- 5
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 70bee334-f6e4-490f-ba59-ad51bf9c9e91
Device Description
25-pack Mitts
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 | 00862800000334 | 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 – 1060 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