AccessGUDID - DEVICE: MBT Sepsityper Kit US IVD (04251204326182)

GUDID

Device Identifier (DI) Information

Brand Name: MBT Sepsityper Kit US IVD
Version or Model: 1867565
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1867565
Company Name: Bruker Daltonik GmbH

Primary DI Number: 04251204326182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 318387958 *Terms of Use

Device Description: Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA

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:	Yes
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?
61336	Mass spectrometry analysis specimen preparation kit IVD	A collection of reagents and other associated materials intended to be used in the preparation of a previously processed clinical specimen (e.g., nucleic acids, proteins) for mass spectrometry analysis (e.g., electrospray ionization, MALDI-TOF). It typically consists of organic/inorganic compound solutions (e.g., imidazole, ammonium bicarbonate) that may added to a volatile solution (e.g., methanol, acetonitrile, hexane) to enable the specimen to disperse into a fine aerosol, and/or promote ionisation of the analyte. The kit can be used with manual or automated instruments.	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
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep the MBT Sepsityper Kit US IVD components out of direct sunlight
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6ced8f8-3a2d-4f39-ac17-962ad3be146d
Public Version Date: August 03, 2023
Public Version Number: 3
DI Record Publish Date: February 11, 2021