AccessGUDID - DEVICE: BD BBL™ Sensi-Disc™ Zone Interpretation Set (00382902606390)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Sensi-Disc™ Zone Interpretation Set
Version or Model: 260639
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 260639
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902606390
Issuing Agency: GS1
Commercial Distribution End Date: September 13, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Set Sensi-Disc Zone Interpretation

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?
35733	Antimicrobial sensitivity disc dispenser IVD	A manually-operated IVD intended to be used for the storage and/or dispensing of antimicrobial sensitivity discs impregnated with antimicrobial agents onto agar or other culture media, for the antimicrobial susceptibility testing of culture isolates from clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTN	SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

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: 90793817-f203-4ea2-b55c-fa2e9cf4737a
Public Version Date: November 18, 2022
Public Version Number: 3
DI Record Publish Date: May 19, 2016