FDA UDI
In Commercial Distribution
🇺🇸 United States
MISSION U500 URINE ANALYZER
DI: 20682607200508
·
Model: U211-101
·
Acon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MISSION U500 URINE ANALYZER
- Primary DI
- 20682607200508
- Version / Model
- U211-101
- Catalog Number
- U211-101
- Company Name
- Acon Laboratories, Inc.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-08
- Public Version
- 3
- Public Version Date
- 2025-06-20
- Public Version Status
- Update
- Public Device Record Key
- bf33e93b-93f6-4a41-8ee8-412bc1b20e4a
Device Description
URINE ANALYZER
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KQO | AUTOMATED URINALYSIS SYSTEM | Clinical Chemistry | 862.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57861 | Urine analyser IVD, point-of-care | A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20682607200508 | GS1 |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit