| Primary Device ID | 30382904913305 |
| NIH Device Record Key | cbe48c6e-4d1a-4841-be57-927b3e79ba4a |
| Commercial Distribution Discontinuation | 2018-05-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BD Settling Chambers |
| Version Model Number | 491330 |
| Catalog Number | 491330 |
| Company DUNS | 103318015 |
| Company Name | TRIPATH IMAGING, INC. |
| Device Count | 240 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-638-8663 |
| technical_services@bd.com | |
| Phone | 800-638-8663 |
| technical_services@bd.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382904913304 [Unit of Use] |
| GS1 | 30382904913305 [Primary] |
| MKQ | Processor, Cervical Cytology Slide, Automated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-05 |
| Device Publish Date | 2015-05-05 |
| 30382904913305 | BD Settling Chambers |
| 30382904913299 | BD Settling Chambers (96). Consumables for use on the PrepStain instrument. |