BD FACS™ 336574
GUDID 00382903365746
BD FACSCalibur FACS Loader
BECTON, DICKINSON AND COMPANY
Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD| Primary Device ID | 00382903365746 |
| NIH Device Record Key | 532a8edb-2b5c-4226-857d-868024bf85f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD FACS™ |
| Version Model Number | 336574 |
| Catalog Number | 336574 |
| Company DUNS | 024230633 |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382903365746 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953302
FDA Product Code
| GKZ | Counter, differential cell |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-08 |
On-Brand Devices [BD FACS™]
| 00382906472052 | BD FACS Sample Prep Assistant III |
| 00382903420650 | FACS Loader For FACSCanto II |
| 00382903383139 | FACSCanto Loader Option IVD |
| 00382903365746 | BD FACSCalibur FACS Loader |
| 00382903357758 | BD FACS 7-Color Setup Beads 25 Tests |
| 00382903364916 | BD FACS™ Lyse Wash Assistant Large External Tank |
Trademark Results [BD FACS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD FACS 85135230 4147329 Live/Registered |
Becton, Dickinson and Company 2010-09-22 |
 BD FACS 77905314 3892275 Live/Registered |
Becton, Dickinson and Company 2010-01-05 |
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