Primary Device ID | 00664369000677 |
NIH Device Record Key | dc64a6ea-8c21-49d3-9a63-973bf277700b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UF-Cellsheath |
Version Model Number | ZA900007 |
Company DUNS | 690664461 |
Company Name | SYSMEX CORPORATION |
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 | 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 | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Total Volume | 20 Liter |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00664369000677 [Primary] |
GIF | Diluent, Blood Cell |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-14 |
Device Publish Date | 2022-11-04 |
00664369000677 | Sheath reagent for fully automated urine particle analyzer |
04987562433926 | UF-CELLSHEATH is a sheath fluid for Sysmex Fully Automated Urine Particle Analyzers. This reagen |