PinAAcle900 Atomic Absorption Spectrometer

Basic Information

• Brand Name: PinAAcle900 Atomic Absorption Spectrometer
• Primary DI: 00812589020542
• Version / Model: N3160051
• Catalog Number: N3160051
• 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: 4291fa5e-9c14-44a9-9ac3-b5e24356acb3

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	00812589020542	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius