cellQART® 968112
GUDID 04260649291375
Fluid specimen concentration filter IVD
SABEU GmbH & Co. KG
Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD Fluid specimen concentration filter IVD| Primary Device ID | 04260649291375 |
| NIH Device Record Key | 2aa6793b-ede3-4d0b-81dc-8b2bd45c82a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cellQART® |
| Version Model Number | cytoQART NON-GYN (LBC) Filters |
| Catalog Number | 968112 |
| Company DUNS | 316894864 |
| Company Name | SABEU GmbH & Co. KG |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com | |
| Phone | +495551910100 |
| info@sabeu.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260649291375 [Unit of Use] |
| GS1 | 04260649291382 [Primary] |
FDA Product Code
| KET | Filters, Cell Collection, Tissue Processing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-11 |
| Device Publish Date | 2021-10-01 |
On-Brand Devices [cellQART®]
| 04260649291399 | Fluid specimen concentration filter IVD |
| 04260649291375 | Fluid specimen concentration filter IVD |
| 04260649291351 | Fluid specimen concentration filter IVD |
Trademark Results [cellQART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLQART 88884918 not registered Live/Pending |
SABEU GmbH & Co. KG 2020-04-23 |
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