Primary Device ID | 05020583419506 |
NIH Device Record Key | bd0ce159-1c72-42a2-85ee-89f95bf73172 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMUGARD |
Version Model Number | 41950 |
Company DUNS | 801679200 |
Company Name | TERUMO BCT, 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 | true |
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 |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Handling Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (box and set level) |
Special Storage Condition, Specify | Between 0 and 0 *Protect from Sun (set level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (box level) |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05020583419506 [Primary] |
GS1 | 35020583419507 [Package] Package: [25 Units] In Commercial Distribution |
KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-01 |
Device Publish Date | 2022-11-23 |
35020583826503 - Trima Accel | 2023-06-27 Trima Accel® LRS® Platelet, Plasma, Auto RBC Set |
05020583910003 - COBE® 2991 | 2023-06-27 Blood Cell Processor |
05020583419506 - IMUGARD | 2022-12-01elabeling.terumobct.com |
05020583419506 - IMUGARD | 2022-12-01 elabeling.terumobct.com |
35020583700315 - Accessory Platelet Bag with Integrated Sampler | 2022-12-01 elabeling.terumobct.com |
05020583112209 - Spectra Optia® | 2022-09-01 Single-Needle Connector |
05020583122208 - Spectra Optia® | 2022-09-01 Exchange Sets |
05020583700703 - Platelet Additive Solution Connection Adapter | 2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER |
05020583705005 - COBE® Spectra | 2022-09-01 Therapeutic Plasma Exchange Set |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IMUGARD 97701483 not registered Live/Pending |
Terumo Kabushiki Kaisha 2022-12-02 |
IMUGARD 73212477 1175993 Dead/Cancelled |
Terumo Kabushiki Kaisha 1979-04-20 |