COBE® Spectra
GUDID 05020583711006
Single Needle Set
TERUMO BCT, INC.
Blood transfer set| Primary Device ID | 05020583711006 |
| NIH Device Record Key | b4328679-b68a-4af7-be72-3cd8f8f4c5af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COBE® Spectra |
| Version Model Number | 71100 |
| 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 | true |
| 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
| 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. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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. |
| 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583711006 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK950065
FDA Product Code
| GKT | Separator, automated, blood cell, diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-13 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [COBE® Spectra ]
| 05020583719002 | Refurbished COBE® Spectra Apheresis System |
| 05020583711006 | Single Needle Set |
| 05020583706200 | White Blood Cell Set- Functionally Closed |
| 05020583703001 | Single-Needle Extended Life Platelet Set With LRS® Chamber |
| 05020583706309 | Bone Marrow Processing Set |
| 05020583706293 | White Blood Cell-Functionally Closed Tubing |
| 05020583706101 | Auto PBSC Set |
| 05020583704008 | Single-Needle Extended Life Platelet Set With LRS® Chamber |
| 05020583701007 | Dual- Needle Extended Life Platelet Set |
| 05020583700109 | Single Needle Set |
| 05020583706002 | COBE Spectra White Blood Cell Set |
| 35020583707000 | Red Blood Cell Exchange Set |
| 35020583705006 | Therapeutic Plasma Exchange Set |
| 05020583707009 | Red Blood Cell Exchange Set |
| 05020583705005 | Therapeutic Plasma Exchange Set |
Trademark Results [COBE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COBE 87669676 not registered Live/Pending |
Cobe ApS 2017-11-02 |
 COBE 87179606 5520203 Live/Registered |
Patrick Campbell 2016-09-22 |
 COBE 86944902 not registered Live/Pending |
Continental Automotive GmbH 2016-03-18 |
 COBE 86785532 5115656 Live/Registered |
Jernudd, Judith G. 2015-10-12 |
 COBE 75908192 not registered Dead/Abandoned |
NET-TEL CORPORATION 2000-02-03 |
 COBE 75018235 2131032 Live/Registered |
TERUMO BCT, INC. 1995-11-13 |
 COBE 74599256 1974362 Dead/Cancelled |
GAMBRO, INC. 1994-11-15 |
 COBE 73725669 1515251 Live/Registered |
COBE LABORATORIES, INC. 1988-05-02 |
 COBE 73181319 1128505 Dead/Cancelled |
COBE LABORATORIES, INC. 1978-08-07 |
 COBE 72403054 0976436 Dead/Expired |
COBE LABORATORIES, INC. 1971-09-20 |
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