BD Totalys™ MultiProcessor Consumables Kit 491453
GUDID 00382904914530
BD Totalys™ MultiProcessor Consumables Kit
BECTON, DICKINSON AND COMPANY
Papanicolaou smear kit Papanicolaou smear kit Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD| 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 |
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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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