FDA UDI
In Commercial Distribution
🇺🇸 United States
Aptiva® System Cleaning Solution Kit
DI: 00195126000871
·
Model: AC1003
·
INOVA DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Aptiva® System Cleaning Solution Kit
- Primary DI
- 00195126000871
- Version / Model
- AC1003
- Company Name
- INOVA DIAGNOSTICS, INC.
- Labeler DUNS
- 188354831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 1
- Public Version Date
- 2024-03-26
- Public Version Status
- New
- Public Device Record Key
- 2461cb2f-de70-4ce3-bfe0-38fe918764a6
Device Description
The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrument Optical Module (OM) and flush the system.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 63377 | Instrument/analyser cleaning agent IVD | A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to in vitro diagnostic devices (e.g., analysers, laboratory instruments, other types of laboratory devices) for pre-cleaning and/or cleaning to remove organic compounds such as blood proteins prior to disinfection or sterilization. It is typically loaded on-board automated or semi-automated instruments for internal cleaning. It typically includes a detergent, and some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195126000871 | GS1 | ||||
| Previous | 08430793041140 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 20 Degrees Celsius