AccessGUDID - DEVICE: AS-150 Anaerobic Chamber (00810048901449)

GUDID

Device Identifier (DI) Information

Brand Name: AS-150 Anaerobic Chamber
Version or Model: AS-150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-150
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048901449
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-150 Anaerobic Chamber is a gloveless anaerobic workstation with a 150 plate capacity in the enclosed incubator. 36" x 24" interior work area.

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?
16335	Anaerobic chamber	An airtight chamber filled with a mixture of oxygen-free gases designed to allow laboratory personnel to culture specimens, observe growth, perform subsequent testing, and incubate cultures under anaerobic conditions. It is typically in the form of a framework covered with a thick, transparent, flexible polyvinyl chloride (PVC) with glove boxes (i.e., sleeve-like ports placed in the sides of the chamber that terminate in thick gloves) which allow the operators to operate and manipulate the object placed in the chamber without compromising it atmosphere.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTM	Anaerobic Box Glove

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: 0734b111-bd86-47ea-9f48-7fa0267b3193
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020