FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756672504
·
Model: 9378-01
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756672504
- Version / Model
- 9378-01
- Catalog Number
- 9378-01
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-29
- Public Version
- 1
- Public Version Date
- 2021-08-06
- Public Version Status
- New
- Public Device Record Key
- b5674624-ed66-4dea-98e4-dcac6efaf638
Device Description
ACTIVE WRAP® REPLACEMENT PACKS
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| IME | Pack, hot or cold, reusable | Physical Medicine | 890.5700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37240 | Hot/cold therapy pack, reusable | 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) 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50749756672509 | GS1 | Case | 48 | In Commercial Distribution | |
| Primary | 00749756672504 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]