AccessGUDID - DEVICE: US IVD-HCCA Matrix, Portioned 10 Tubes (04251204325659)

GUDID

Device Identifier (DI) Information

Brand Name: US IVD-HCCA Matrix, Portioned 10 Tubes
Version or Model: 8604531
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8604531
Company Name: Bruker Daltonik GmbH

Primary DI Number: 04251204325659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 318387958 *Terms of Use

Device Description: HCCA Matrix, 10 tubes

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?
61954	Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs for the preparation or processing of a clinical specimen for subsequent liquid chromatography and/or mass spectrometry (LC/MS) separation and/or analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEX	System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

FDA Premarket Submission

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

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
Special Storage Condition, Specify: Min stability 2 years.
Special Storage Condition, Specify: Max 8hr working time unrefridgerated.
Handling Environment Temperature: between 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cfbdcb4-cda7-42f3-bec5-800986aa1298
Public Version Date: September 26, 2022
Public Version Number: 5
DI Record Publish Date: February 25, 2017