Primary Device ID | 00816394020902 |
NIH Device Record Key | d2e711c3-4b91-456b-b763-ed8e5f80e62e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UltraCW® |
Version Model Number | UltraCW |
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 | false |
OTC Over-The-Counter | false |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
Phone | 317-773-9073 |
techservice@helmerinc.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816394020902 [Primary] |
KSN | Centrifuge, Cell-Washing, Automated For Immuno-Hematology |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-07-01 |
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 |
00816394020964 - i.Series® | 2019-03-11 Platelet Incubator |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTRACW 78197386 2852009 Live/Registered |
HELMER, INC. 2002-12-23 |