FDA UDI
In Commercial Distribution
🇺🇸 United States
Healy
DI: 04251784906101
·
Model: 0006
·
Healy GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Healy
- Primary DI
- 04251784906101
- Version / Model
- 0006
- Company Name
- Healy GmbH
- Labeler DUNS
- 314161135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-10
- Public Version
- 1
- Public Version Date
- 2025-07-18
- Public Version Status
- New
- Public Device Record Key
- 11a38629-a155-4f93-9fdc-64620a8913f9
Device Description
The device is a variant of the Healy device with primary DI number 04251784906033. This device is available in Wave format instead of the standard whit color.
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
- 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 |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46668 | Blood storage solution, multi-purpose | A blood preservation fluid that is used during the collection and storage of blood and blood components in a healthcare and/or a blood bank facility (typically in a laboratory associated with the collection of blood or during apheresis procedures that result in the collection of blood), to perform more than one blood preservation function such as anticoagulation, provision of blood cell nutritional needs, and/or support during blood freezing. It is supplied in a container (e.g., a polypropylene bag) and is not for direct intravenous infusion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251784906101 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191075 | 000 |