TSCD®-II
GUDID 05020583620032
Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder
TERUMO BCT, INC.
Package sealing unit| Primary Device ID | 05020583620032 |
| NIH Device Record Key | bde22bce-0d8d-4425-84f9-066bf3c53c08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSCD®-II |
| Version Model Number | 62003 |
| Company DUNS | 801679200 |
| Company Name | TERUMO BCT, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Excessive Heat |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Freezing |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583620032 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK860041
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 | 2019-12-11 |
| Device Publish Date | 2017-09-15 |
On-Brand Devices [TSCD®-II ]
| 05020583620032 | Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder |
| 05020583620001 | Terumo Sterile Tubing Welder |
| 05020583300064 | 3-Ncc947 Weld Integrity Test Kit |
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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