AccessGUDID - DEVICE: Advanced Instruments Palladox Disposable Satchet (00816068020962)

GUDID

Device Identifier (DI) Information

Brand Name: Advanced Instruments Palladox Disposable Satchet
Version or Model: AN3146
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AN3146
Company Name: ADVANCED INSTRUMENTS, INC.

Primary DI Number: 00816068020962
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125006353 *Terms of Use

Device Description: The new single use Palladox disposable sachet is designed specifically to work with the Anoxomat System. The easy-to-use, single-use catalyst will simplify your anaerobic sample testing by minimizing catalyst handling time. The Palladox sachet reduces the oxygen in the jar in minutes and maintains an anaerobic environment for the duration of incubation. This product is the perfect solution to improve workflow efficiency, eliminate downtime and simplify anaerobic testing.

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):	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
Storage Environment Temperature: between 2 and 22 Degrees Celsius
Storage Environment Humidity: between 0 and 50 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7cb49333-ff95-4003-8408-bde065a731b7
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020