AccessGUDID - DEVICE: Artificial Atmosphere Mixture (00860009502031)

GUDID

Device Identifier (DI) Information

Brand Name: Artificial Atmosphere Mixture
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Roberts Oxygen Company, Inc.

Primary DI Number: 00860009502031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791818008 *Terms of Use

Device Description: Used to grow and sustain anaerobic, aerobic bacteria, or cultures in a biological incubator.

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":	Yes
For Single-Use:	Yes
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?
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
BXK	Gas, Calibration (Specified Concentration)

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: 7f3fb19a-3bc8-495a-9eca-0cb2027c3340
Public Version Date: November 23, 2022
Public Version Number: 1
DI Record Publish Date: November 15, 2022