FDA UDI
In Commercial Distribution
🇺🇸 United States
Ezy Dose
DI: 00025715232973
·
Model: 23297
·
APOTHECARY PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Ezy Dose
- Primary DI
- 00025715232973
- Version / Model
- 23297
- Company Name
- APOTHECARY PRODUCTS, LLC
- Labeler DUNS
- 092312735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-11-16
- Public Version
- 1
- Public Version Date
- 2020-11-24
- Public Version Status
- New
- Public Device Record Key
- 83883e32-ed27-484a-9dfc-9b0f00961617
Device Description
UNIVERSAL PH INDICATOR
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | 862.1550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63695 | Urine test strip colour chart IVD | A device in the form of a printed chart designed for the qualitative and semi-quantitative assessment of urine analyte (e.g., ketones, glucose, nitrites, leukocytes) concentration/pH by visually comparing urine test strip colour with a standard scale of colour variations that correlate with urine analyte concentration/pH. It is typically used to screen paediatric urine by clinicians in a healthcare facility or by laypersons in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10125715232977 | GS1 | case | 144 | In Commercial Distribution | |
| Primary | 00025715232973 | GS1 | ||||
| Unit of Use | 40025715232858 | GS1 |
Customer Contacts
- Phone
- 952-890-1940
- [email protected]