AccessGUDID - DEVICE: Anaerobic Mixture (00860009591806)

GUDID

Device Identifier (DI) Information

Brand Name: Anaerobic Mixture
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Industrial Source

Primary DI Number: 00860009591806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801576526 *Terms of Use

Device Description: GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Anaerobic Mixture

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: 42543ed2-a2c0-41c4-afae-2e4bf4fc2004
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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