AccessGUDID - DEVICE: HPLC Cartridge (iHPLC) (07613336228630)

GUDID

Device Identifier (DI) Information

Brand Name: HPLC Cartridge (iHPLC)
Version or Model: 09511725190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 09511725190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336228630
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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?
44407	High performance liquid chromatography analyser column IVD	A component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various chemical and physical properties and their interaction with a specific column filling. The internal diameter of the HPLC tubing (typically ranges from under 0.3 mm to greater than 10 mm) determines the quantity of analyte that can be loaded and analyser sensitivity. The tubes are made of various materials including stainless steel and fused silica.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DPM	COLUMNS, 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: e88ceb3b-af8d-47f1-9139-a45667f4ce56
Public Version Date: August 08, 2025
Public Version Number: 1
DI Record Publish Date: July 31, 2025