AccessGUDID - DEVICE: BacterioScan 216Dx System (B9090051)

GUDID

Device Identifier (DI) Information

Brand Name: BacterioScan 216Dx System
Version or Model: Clear Cartridge - 4 Well Tray
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BACTERIOSCAN, INC.

Primary DI Number: B9090051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 029599160 *Terms of Use

Device Description: Disposable used in system

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:	Yes
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?
63609	Microbial incubator/imaging system IVD	An electrically-powered device intended to provide ideal conditions for microbial growth with an incubator, and to capture digital images of the specimens contained within the incubator at specified time intervals. It consists of an incubator unit with multiple shelves, a camera and a display unit for microbial growth monitoring. The system automatically monitors and controls temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It may have an integrated robotic transfer arm for loading and unloading the incubator onto/from other instruments. The device may be a single unit or modular assembly.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBQ	System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172412	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d589db6-bb11-4a6f-b4c3-d73cca67b1e2
Public Version Date: October 29, 2020
Public Version Number: 1
DI Record Publish Date: October 21, 2020