Primary Device ID | 00816394021664 |
NIH Device Record Key | f6461b7f-b741-49e1-8340-6bc2590a4b42 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Helmer |
Version Model Number | PC4200-Pro |
Company DUNS | 086685682 |
Company Name | HELMER, INC. |
Device Count | 1 |
DM Exempt | false |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816394021664 [Primary] |
KSH | Chamber, Environmental For The Storage Of Platelet Concentrate |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-05-09 |
Device Publish Date | 2022-12-30 |
00816394021664 - Helmer | 2024-05-09Environmentatal chamber for storage of platelet concentrate |
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 |
---|---|
HELMER 86103845 4559456 Live/Registered |
NINGBO WELAND IMP & EXP CO., LTD. 2013-10-29 |
HELMER 77625775 3668805 Live/Registered |
Helmer Inc. 2008-12-03 |