AccessGUDID - DEVICE: US IVD-Bruker Bacterial Test Standard, 5 Tubes (04251204325642)

GUDID

Device Identifier (DI) Information

Brand Name: US IVD-Bruker Bacterial Test Standard, 5 Tubes
Version or Model: 8604530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8604530
Company Name: Bruker Daltonik GmbH

Primary DI Number: 04251204325642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 318387958 *Terms of Use

Device Description: Bacterial Test Standard, 5 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?
61947	Brain-responsive electrical stimulation system	An assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting.	Active	true

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: Max 8hr working time unrefridgerated.
Special Storage Condition, Specify: Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
Storage Environment Temperature: exactly -18 Degrees Celsius
Handling Environment Temperature: between 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e28ac8d-8b5b-4d90-aef0-311cd0200f4e
Public Version Date: September 26, 2022
Public Version Number: 4
DI Record Publish Date: February 25, 2017