AccessGUDID - DEVICE: BD BBL™ Bio-Bag™ Environmental Chamber Type C (30382902612125)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Bio-Bag™ Environmental Chamber Type C
Version or Model: 261212
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 261212
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902612125
Issuing Agency: GS1
Commercial Distribution End Date: September 28, 2021
Device Count: 25
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Bag Bio-Bag Type Cfj 25 Ea

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):	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 755f1c5c-f9cf-430f-9ce4-0984bd01bd70
Public Version Date: November 18, 2022
Public Version Number: 2
DI Record Publish Date: May 25, 2018