US IVD-Bruker Bacterial Test Standard, 5 Tubes

Basic Information

• Brand Name: US IVD-Bruker Bacterial Test Standard, 5 Tubes
• Primary DI: 04251204325642
• Version / Model: 8604530
• Catalog Number: 8604530
• Company Name: Bruker Daltonik GmbH
• Labeler DUNS: 318387958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-02-25
• Public Version: 4
• Public Version Date: 2022-09-26
• Public Version Status: Update
• Public Device Record Key: 9e28ac8d-8b5b-4d90-aef0-311cd0200f4e

Device Description

Bacterial Test Standard, 5 tubes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEX	System, mass spectrometry, maldi tof, microorganism identification, cultured isolates	Microbiology	866.3361	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251204325642	GS1
Unit of Use	04251204325758	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Max 8hr working time unrefridgerated.
• Type: Special Storage Condition, Specify
• Special Conditions: Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
• Type: Storage Environment Temperature
• Temperature Range: -18 – -18 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit