Primary Device ID | 14987562460301 |
NIH Device Record Key | a605d3dc-a3d0-46d2-93c3-a4948ed5d426 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XN CHECK |
Version Model Number | 213499 |
Company DUNS | 690664461 |
Company Name | SYSMEX CORPORATION |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com |
Total Volume | 3 Milliliter |
Total Volume | 3 Milliliter |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 14987562460301 [Primary] |
JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-09-18 |
Device Publish Date | 2016-08-05 |
14987562460301 | XN CHECK 12X3.0ML L1,2,3 |
14987562502766 | XN CHECK 8 x 3.0mL, Level 3 |
14987562502759 | XN CHECK 8 x 3.0mL, Level 2 |
14987562502742 | XN CHECK 8 x 3.0mL, Level 1 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XN CHECK 85147679 4315470 Live/Registered |
Sysmex Corporation 2010-10-07 |