TSCD®
GUDID 05020583300040
Weld Integrity Test Kit
TERUMO BCT, INC.
Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit Package sealing unit| Primary Device ID | 05020583300040 |
| NIH Device Record Key | a498f416-4386-49ea-8ff6-e0ae8dd4d3ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSCD® |
| Version Model Number | 3NCC945 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583300040 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK110071
FDA Product Code
| KSB | SET, TRANSFER (BLOOD/PLASMA) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2016-09-15 |
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 | 2022-12-01 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 [TSCD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TSCD 74574203 1958498 Live/Registered |
TERUMO KABUSHIKI KAISHA 1994-09-14 |
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