IMUGARD
GUDID 05020583419506
elabeling.terumobct.com
TERUMO BCT, INC.
Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583419506 [Primary] |
| GS1 | 35020583419507 [Package] Package: [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK210658
FDA Product Code
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-01 |
| Device Publish Date | 2022-11-23 |
Devices Manufactured by TERUMO BCT, INC.
| 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 |
Trademark Results [IMUGARD]
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 |
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