Primary Device ID | 00816394020650 |
NIH Device Record Key | e0b1697d-6e75-49ea-8123-fd2f3423ba9c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | QuickThaw® |
Version Model Number | DH8 |
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 | 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 | |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
Phone | 317-773-9073 |
techservice@helmerinc.com | |
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 | 00816394020650 [Primary] |
LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
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 |
00816394020667 | Plasma Thawing System |
00816394020650 | Plasma Thawing System |
00816394020643 | Plasma Thawing System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUICKTHAW 87850703 5754743 Live/Registered |
Quickthaw LLC 2018-03-26 |
QUICKTHAW 87283800 not registered Dead/Abandoned |
QUICKTHAW LLC 2016-12-29 |
QUICKTHAW 77625774 3672135 Live/Registered |
Helmer Inc. 2008-12-03 |