IMUGARD
GUDID 05020583419506
elabeling.terumobct.com
TERUMO BCT, INC.
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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