AccessGUDID - DEVICE: BD GasPak™ 100 Lid (00382902604112)

GUDID

Device Identifier (DI) Information

Brand Name: BD GasPak™ 100 Lid
Version or Model: 260411
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 260411
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902604112
Issuing Agency: GS1
Commercial Distribution End Date: June 26, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD GasPak™ 100 Lid

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?
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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4107b0f2-85fc-42ed-865e-98d4646b1b9c
Public Version Date: June 27, 2025
Public Version Number: 3
DI Record Publish Date: May 25, 2018