AccessGUDID - DEVICE: Advanced Instruments Ergonomic Culture Jar, Large (00816068020924)

GUDID

Device Identifier (DI) Information

Brand Name: Advanced Instruments Ergonomic Culture Jar, Large
Version or Model: AJ9050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AJ9050
Company Name: ADVANCED INSTRUMENTS, INC.

Primary DI Number: 00816068020924
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125006353 *Terms of Use

Device Description: The Advanced Instruments ergonomic anaerobic jars provide flexibility and ease of use for laboratory technicians while maximizing incubator and laboratory space. All Anoxomat jars are built to meet the highest microbiological and mechanical standards and minimize the risk of oxygen leaks. The large jar has a capacity of 24 petri dishes

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):	No
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?
43530	Anaerobic (AnO2) atmospheric generation IVD	A pouch or unit intended to be used to reduce or deplete atmospheric oxygen (AnO2) to create an anaerobic environment suitable for the cultivation, processing, or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZJ	Device, Gas Generating

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: c06fe338-c8fb-43f2-9a2e-4a82a4e7050c
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020