FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptiva® System Rinse
DI: 08430793041157
·
Model: AC1004
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aptiva® System Rinse
- Primary DI
- 08430793041157
- Version / Model
- AC1004
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 1
- Public Version Date
- 2024-03-19
- Public Version Status
- New
- Public Device Record Key
- 059b4372-9dd7-4b8c-b908-bfcd9b2fcb61
Device Description
The Aptiva System Rinse is intended for use on the Inova Diagnostics Aptiva Multi-Analyte Instrument. System Rinse is intended as a system fluid and predilution buffer on the Aptiva Multi-Analyte Instrument.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58236 | Buffered wash solution IVD | A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08430793041157 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius