FDA UDI
In Commercial Distribution
🇺🇸 United States
Minncare HD
DI: 00724995223298
·
Model: 3029764
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Minncare HD
- Primary DI
- 00724995223298
- Version / Model
- 3029764
- Catalog Number
- 3029764
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-26
- Public Version
- 1
- Public Version Date
- 2024-04-03
- Public Version Status
- New
- Public Device Record Key
- dfb549cb-b6e6-4ab7-a4ea-b00aade04339
Device Description
Minncare HD (4 x 1 Gallon)
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NIH | Disinfectant, subsystem, water purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40580 | Organic peroxy acid device sterilant, single-use | A substance in liquid or powder (reconstituted with water) form that includes an organic peroxy acid (e.g., peracetic acid, perpyruvic acid) as its primary agent intended to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50724995223293 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00724995223298 | GS1 | ||||
| Previous | 00677964066863 | GS1 |
Customer Contacts
- Phone
- +1(800)444-4729
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133724 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 75 Degrees Fahrenheit