FDA UDI
In Commercial Distribution
🇺🇸 United States
PinAAcle900 Atomic Absorption Spectrometer
DI: 00812589020566
·
Model: N3160082
·
REVVITY SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PinAAcle900 Atomic Absorption Spectrometer
- Primary DI
- 00812589020566
- Version / Model
- N3160082
- Catalog Number
- N3160082
- Company Name
- REVVITY SINGAPORE PTE. LTD.
- Labeler DUNS
- 894632777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-14
- Public Version
- 2
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 504e0a8c-b33b-4fee-84d4-514e87314a87
Device Description
For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JXR | Atomic Absorption Spectrophotometer, General Use | Clinical Chemistry | 862.2850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57811 | Atomic absorption spectrophotometer IVD, semi-automated | A mains electricity (AC-powered) laboratory instrument intended to be used to measure the emission, absorption, or fluorescence of electromagnetic radiation by atomic particles following atomization, most commonly by flame or furnace, to determine the concentration of a chemical and/or biological marker in a clinical specimen (e.g., electrolytes, essential trace elements, or metals in body tissues/fluids that may have been used in therapy or resulted from exposure to industrial and environmental pollutants). The device operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812589020566 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius