AccessGUDID - DEVICE: BD BBL™ GasPak™ 100 Anaerobic System (00382902606260)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ GasPak™ 100 Anaerobic System
Version or Model: 260626
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 260626
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902606260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ GasPak™ 100 Anaerobic System

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):	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?
43520	Atmospheric generation kit IVD	A pouch, unit, and/or other accessories intended to be used in combination to generate specific atmospheric conditions [e.g., increased carbon dioxide (CO2), reduced or depleted oxygen (AnO2)] as an 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1ae042f-67de-4352-80ac-2be12113ed27
Public Version Date: October 30, 2024
Public Version Number: 2
DI Record Publish Date: May 25, 2018