UltraCW®II N/A
GUDID 00816394020933
Automated Cell Washing System
HELMER, INC.
Cell washer IVD| Primary Device ID | 00816394020933 |
| NIH Device Record Key | 69efa694-e2f2-4305-b541-c6d1f248c9a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraCW®II |
| Version Model Number | UltraCW II |
| Catalog Number | N/A |
| Company DUNS | 086685682 |
| Company Name | HELMER, INC. |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 317-7739073 |
| techservice@helmerinc.com | |
| Phone | 317-7739073 |
| techservice@helmerinc.com | |
| Phone | 317-7739073 |
| techservice@helmerinc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816394020933 [Primary] |
FDA Product Code
| KSN | Centrifuge, Cell-Washing, Automated For Immuno-Hematology |
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 | 2018-05-14 |
| Device Publish Date | 2018-04-13 |
Devices Manufactured by HELMER, INC.
| 00816394021824 - Farrar | 2025-01-20 Ultralow temperature freezer |
| 00816394021664 - Helmer | 2024-05-09 Environmentatal chamber for storage of platelet concentrate |
| 00816394021695 - i.Series® | 2023-10-16 Blood Bank Compartmental Access Refrigerator 20 Bin |
| 00816394021770 - i.Series® | 2023-10-10 Blood Bank Compartmental Access Refrigerator 80 Bin |
| 00816394021671 - i.Series Platelet Incubator | 2022-12-09 Environmentatal chamber for storage of platelet concentrate |
| 00816394021688 - i.Series Platelet Incubator | 2022-12-09 Environmentatal chamber for storage of platelet concentrate |
| 00816394020940 - i.Series® | 2019-03-11 Platelet Incubator |
| 00816394020957 - i.Series® | 2019-03-11 Platelet Incubator |
Trademark Results [UltraCW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRACW 78197386 2852009 Live/Registered |
HELMER, INC. 2002-12-23 |
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