AccessGUDID - DEVICE: Jasper HPLC System (00842365100519)

GUDID

Device Identifier (DI) Information

Brand Name: Jasper HPLC System
Version or Model: 5057029
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AB SCIEX (MANUFACTURING)

Primary DI Number: 00842365100519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595281292 *Terms of Use

Device Description: The Jasper HPLC system is a high pressure liquid chromatography system for clinical use intended to separate one or more compounds from a solution by processing the mixture of compounds (solutes) through a column packed with a solid absorbent material (stationary phase) under the influence of a high pressure liquid (mobile phase). This system is intended to be used in tandem with a mass spectrometer system for compound detection.

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?
57845	High performance liquid chromatography analyser IVD	An electrically-powered automated or semi-automated laboratory instrument designed for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Chemical components are separated by passing pressurized liquid through a narrow column to allow the various components to separate based on their chemical/physical properties while interacting with column filling. As the substances exit the column they are detected and identified electronically or spectrometrically. The device is used for the identification of complex substances such as drugs and hormones.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIE	Apparatus, High Pressure Liquid Chromatography

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe72a994-fc01-43c0-87c3-90c5d35492d6
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022