FDA UDI
In Commercial Distribution
🇺🇸 United States
Arctic Flex
DI: 00810113576077
·
Model: SUP3054
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Arctic Flex
- Primary DI
- 00810113576077
- Version / Model
- SUP3054
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-10
- Public Version
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- 2adc42fe-b2b7-4e77-be05-fa72cb8463e9
Device Description
Wrist Ice Wrap (Cryogrid)
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| ILH | Splint, Hand, And Components | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37240 | Musculoskeletal hot/cold therapy pack, reusable | A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113576074 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00810113576077 | GS1 |