FDA UDI
In Commercial Distribution
🇺🇸 United States
Therm-X
DI: 00850001096577
·
Model: Therm-X Butterfly Knee Small, SPU
·
ZENITH TECHNICAL INNOVATIONS, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Therm-X
- Primary DI
- 00850001096577
- Version / Model
- Therm-X Butterfly Knee Small, SPU
- Catalog Number
- TX0315
- Company Name
- ZENITH TECHNICAL INNOVATIONS, LLC
- Labeler DUNS
- 062931546
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-13
- Public Version
- 1
- Public Version Date
- 2026-02-23
- Public Version Status
- New
- Public Device Record Key
- 6483a00f-6f6d-4a0b-9ebf-ea267ebdacc8
Device Description
Therm-X Butterfly Knee Small, SPU
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 |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 870.5800 | 2 |
| ILO | Pack, Hot Or Cold, Water Circulating | Physical Medicine | 890.5720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61429 | Inflatable hot/cold therapy pack/electric pump | A non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs with an air inflation sleeve, a mains electricity (AC-powered) air pump with controls, and air-conduction tubing; the pack(s) is heated/cooled independently of the system (e.g., cooled using chilling unit) and may be anatomically specific. The unit may be programmed for selected treatment plans. It is intended for use in both professional and home settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850001096577 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- – 60 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 33 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 33 – 102 Degrees Fahrenheit