FDA UDI
In Commercial Distribution
🇺🇸 United States
THERAPY SYSTEM, ARTEK PRO-02
DI: 00850033615647
·
Model: 0P9PTATP02
·
THERMOTEK, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- THERAPY SYSTEM, ARTEK PRO-02
- Primary DI
- 00850033615647
- Version / Model
- 0P9PTATP02
- Catalog Number
- 0P9PTATP02
- Company Name
- THERMOTEK, INC.
- Labeler DUNS
- 847899911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-23
- Public Version
- 1
- Public Version Date
- 2026-03-03
- Public Version Status
- New
- Public Device Record Key
- c8da7151-5359-4d68-beac-a83506dc770a
Device Description
THERAPY SYSTEM, ARTEK PRO-02
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
- No
- 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 |
|---|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | Physical Medicine | 890.5720 | 2 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40485 | Circulating-fluid localized thermal therapy system pack, single-use | A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device. | No | Active |
| 60708 | Circulating-fluid localized thermal/compression therapy system wrap | A non-sterile component of a circulating-fluid localized thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033615647 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061866 | 000 |