AccessGUDID - DEVICE: HPLC Column (04250317513618)

GUDID

Device Identifier (DI) Information

Brand Name: HPLC Column
Version or Model: 6100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6100
Company Name: Chromsystems Instruments + Chemicals GmbH

Primary DI Number: 04250317513618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328712260 *Terms of Use

Device Description: HPLC Column, Catecholamines in urine

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?
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
KZR	Chromatography (Liquid, Gel), Clinical 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 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 pcs.

Device Record Status

Public Device Record Key: afcf1712-b21c-4403-be69-302f332b248c
Public Version Date: August 28, 2020
Public Version Number: 1
DI Record Publish Date: August 20, 2020