BD Totalys™ MultiProcessor Consumables Kit 491453
GUDID 00382904914530
BD Totalys™ MultiProcessor Consumables Kit
BECTON, DICKINSON AND COMPANY
Papanicolaou smear kit| Primary Device ID | 00382904914530 |
| NIH Device Record Key | f8ad8e50-b7f6-42c6-9748-7ef36dd3fdfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD Totalys™ MultiProcessor Consumables Kit |
| Version Model Number | 491453 |
| Catalog Number | 491453 |
| Company DUNS | 122561087 |
| Company Name | BECTON, DICKINSON AND COMPANY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_Services@bd.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382904914530 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970018
FDA Product Code
| MKQ | Processor, cervical cytology slide, automated |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-19 |
| Device Publish Date | 2018-08-22 |
Devices Manufactured by BECTON, DICKINSON AND COMPANY
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| 30382902461006 - BD Kiestra™ Isolate Suspension Cuvette Array | 2024-11-27 BD Kiestra™ Isolate Suspension Cuvette Array |
| 50382903032780 - Eclipse Needle | 2024-11-21 NEEDLE ECLIPSE 23X1-1/2 RB TW BNS |
| 60382904454755 - BD BACTEC™ 9240 | 2024-11-12 BD BACTEC™ 9240 |
| 60382904455707 - BD BACTEC™ 9120 | 2024-11-12 BD BACTEC™ 9120 |
| 00382904458003 - BD BACTEC™ 9050 | 2024-11-11 BD BACTEC™ 9050 |
| 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube | 2024-11-11 BD Onclarity HPV Self Collection Diluent Tube |
Trademark Results [BD Totalys]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD TOTALYS 86839210 5210228 Live/Registered |
Becton, Dickinson and Company 2015-12-04 |
 BD TOTALYS 85598678 not registered Dead/Abandoned |
Becton, Dickinson and Company 2012-04-16 |
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