BD Density Reagent (480 ml) 491332

GUDID 00382904913328

BD Density Reagent (480mL)

BECTON, DICKINSON AND COMPANY

Cell centrifugation/density gradient separation reagent IVD
Primary Device ID00382904913328
NIH Device Record Keyba5a9968-e441-4e65-aa3b-43c8026ad242
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Density Reagent (480 ml)
Version Model Number491332
Catalog Number491332
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com

Device Dimensions

Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter
Total Volume480 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904913328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKQProcessor, Cervical Cytology Slide, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-11
Device Publish Date2017-09-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

50382903247054 - BD Insulin Syringe2024-12-16 U-100 Insulin Syringe, 1.0mL, 27G x 12.7mm
00382902900207 - BD Sputum Collection System2024-11-27 BD Sputum Collection System, Case of 72 units
30382902461006 - BD Kiestra™ Isolate Suspension Cuvette Array2024-11-27 BD Kiestra™ Isolate Suspension Cuvette Array
50382903032780 - Eclipse Needle2024-11-21 NEEDLE ECLIPSE 23X1-1/2 RB TW BNS
60382904454755 - BD BACTEC™ 92402024-11-12 BD BACTEC™ 9240
60382904455707 - BD BACTEC™ 91202024-11-12 BD BACTEC™ 9120
00382904458003 - BD BACTEC™ 90502024-11-11 BD BACTEC™ 9050
00382904454166 - BD Onclarity HPV Self Collection Diluent Tube2024-11-11 BD Onclarity HPV Self Collection Diluent Tube

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.