AccessGUDID - DEVICE: PinAAcle900 Atomic Absorption Spectrometer (00812589020542)

GUDID

Device Identifier (DI) Information

Brand Name: PinAAcle900 Atomic Absorption Spectrometer
Version or Model: N3160051
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N3160051
Company Name: REVVITY SINGAPORE PTE. LTD.

Primary DI Number: 00812589020542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 894632777 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JXR	Atomic Absorption Spectrophotometer, General Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4291fa5e-9c14-44a9-9ac3-b5e24356acb3
Public Version Date: June 22, 2023
Public Version Number: 2
DI Record Publish Date: May 14, 2020