AccessGUDID - DEVICE: BD BBL™ Haemophilus Test Medium Agar (HTM Agar) (10382902219542)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Haemophilus Test Medium Agar (HTM Agar)
Version or Model: 221954
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221954
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902219542
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2022
Device Count: 4
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Plate Haemophilus Test Medium Agar 8 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?
58611	Haemophilus species antimicrobial susceptibility culture medium IVD	A supplemented culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on Haemophilus species isolated from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSO	CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K894216	000

Device Exempt from Premarket Submission: No 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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 15 Millimeter
Outer Diameter: 150 Millimeter

Device Record Status

Public Device Record Key: 3696d5b1-0fbe-4932-a951-2d1d43c18578
Public Version Date: October 13, 2023
Public Version Number: 4
DI Record Publish Date: December 21, 2016