AccessGUDID - DEVICE: BD BBL&#8482; Catalase Reagent Dropper (30382902612033)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Catalase Reagent Dropper
Version or Model: 261203
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 261203
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902612033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Catalase Reagent Dropper

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?
42736	Catalase production microbial reagent IVD	A substance or reactant, sometimes referred to as hydrogen peroxide reagent, intended to be used in microbial testing to detect the enzyme catalase produced by a microorganism isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

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
Total Volume: 0.5 Milliliter

Device Record Status

Public Device Record Key: a3f1f846-2a91-4c72-8e10-6df96164b5e6
Public Version Date: June 25, 2018
Public Version Number: 1
DI Record Publish Date: May 25, 2018