FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoart
DI: E307232300200
·
Model: MONOART INSTANT ICE
·
EURONDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Monoart
- Primary DI
- E307232300200
- Version / Model
- MONOART INSTANT ICE
- Catalog Number
- 23230020
- Company Name
- EURONDA SPA
- Labeler DUNS
- 428755441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-26
- Public Version
- 1
- Public Version Date
- 2019-08-05
- Public Version Status
- New
- Public Device Record Key
- 126eaf5a-192c-43b6-939e-d0ed8a42c0db
Device Description
Monoart Istant Ice guaratees better quality and longer lasting cooling. Disposable bag made of K2P-cellulosa. Shelf life: 5 years. Size 150x175 mm. Carton of 24 bags.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40555 | Hot/cold therapy pack, single-use | A non-sterile 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, peat) 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E307232300200 | HIBCC |