BD BBL™ DrySlide™ PYR Kit

Basic Information

• Brand Name: BD BBL™ DrySlide™ PYR Kit
• Primary DI: 00382902317470
• Version / Model: 231747
• Catalog Number: 231747
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 1
• Public Version Date: 2018-06-25
• Public Version Status: New
• Public Device Record Key: 1f2f8934-49f1-4a6d-8956-42b5217e7515

Device Description

BD BBL™ DrySlide™ PYR Kit Contains: 15 each DrySlide PYR slides and (0.5 mL) Color Developer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTO	DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35998	Pyrrolidonyl arylamidase (PYR) microbial reagent IVD	A substance or reactant intended to be used in microbial testing for the detection of pyrrolidonyl arylamidase (PYR) production and/or activity, for the presumptive identification of beta-haemolytic Streptococcus (Lancefield) group A and Enterococcus species (Lancefield) group D bacteria, activity in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382902317470	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius