AccessGUDID - DEVICE: Piccolo Xpress (EABA110000001)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Xpress
Version or Model: 1100-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100-0000
Company Name: ABAXIS, INC.

Primary DI Number: EABA110000001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 555503770 *Terms of Use

Device Description: The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing. It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests. Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required. The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.

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):	No
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?
35744	Centrifugal clinical chemistry analyser	A mains electricity (AC-powered) automatic or semi-automated instrument that uses centrifugal force to transfer and mix liquids. It also monitors the resulting reactions in the centrifuge with, e.g., a photometer. A separate unit is required for dispensing samples and reagents.	Obsolete	false

FDA Product Code

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Product Code	Product Code Name
JJG	Analyzer, Chemistry, Centrifugal, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934592	000

Device Exempt from Premarket Submission: No 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
Handling Environment Humidity: between 8 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 59 and 90 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 32 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Weight: 5.3 Kilogram
Depth: 21.0 Centimeter
Width: 14.9 Centimeter
Height: 32.5 Centimeter

Device Record Status

Public Device Record Key: 3dd1b7ea-4ef6-4a2e-ba77-2a435ab5a32e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016