SOLO-TRAK®-KR
GUDID 00681490143103
INTRO 6208BTK-D1 INTROD 8FR DUAL CH 10L
MEDTRONIC, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 00681490143103 |
| NIH Device Record Key | b3b8299c-4961-4527-b0e7-02d36e046b0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLO-TRAK®-KR |
| Version Model Number | 6208BTK-D1 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490143103 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K965167
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2019-06-07 |
| Device Publish Date | 2017-01-03 |
On-Brand Devices [SOLO-TRAK®-KR]
| 10681490143735 | INTRO 6212BTK-5 5PK 12FR |
| 10681490143599 | INTRO 6211BTK5 5PK BRAIDED |
| 00681490143585 | INTRO 6211BTK-1 1PK INTRODUCER 11FR 10L |
| 00681490143448 | INTRO 6210BTKL1 KINK RESIST X-LONG 10L |
| 00681490143431 | ACCESS 6210BTK-D1 INTRODUCER 10F |
| 10681490143421 | INTRO 6210BTK-5 5PK 10FR 10L |
| 00681490143417 | INTRO 6210BTK-1 1PK INTRODUCER 10FR 10L |
| 00681490143288 | INTRO 6209BTKL1 KINK RESISTEX LONG 10L |
| 00681490143271 | INTRO 6209BTK-D1 INTROD 9FR DUAL CH 10L |
| 10681490143261 | INTRO 6209BTK-5 5PK 9FR 10L |
| 00681490143257 | INTRO 6209BTK-1 1PK INTRODUCER 9FR 10L |
| 00681490143110 | LEAD 6208BTKL1 INTRO-KINK RES EX LG 10L |
| 00681490143103 | INTRO 6208BTK-D1 INTROD 8FR DUAL CH 10L |
| 10681490143094 | INTRODUCER 6208BTK5 LEAD BRAIDED 5PK |
| 00681490143080 | INTRO 6208BTK-1 1PK INTRODUCER 8FR 10L |
| 00681490142960 | PLI 6207BTKL1 SOLOTRAK KINK RESIS EX LNG |
| 00681490142953 | INTRO 6207BTK-D1 7FR DC 10L |
| 10681490142943 | INTRO 6207BTK-5 5PK J5 7 FR |
| 00681490142939 | INTRO 6207BTK-1 7FR SINGLE 10L |
| 00721902577451 | PLI 6210BTKL1S SOLOTRAK XLG W/SN 10.5FR |
| 00721902577437 | INTRODUCER 6209BTKL1S LEAD SGL PK SGL CH |
| 00721902577413 | INTRODUCER 6208BTKL1S LEAD SGL PK SGL CH |
| 00721902577406 | PLI 6207BTKL1S SOLTRAK X LG W/SN 7FR |
| 10721902577304 | PLI 6210BTK5S SOLOTRAK W/SN 10.5FR 5PK |
| 10721902577281 | PLI 6209BTK5S SOLOTRAK W/SN 9FR |
| 10721902577274 | PLI 6208BTK5S SOLOTRAK W/SN 8FR |
| 10721902577267 | PLI 6207BTK5S SOLOTRAK W/SN 7FR |
| 00721902577192 | PLI 6209BTK1S SOLOTRAK W/SN 9FR |
| 00721902577178 | PLI 6208BTK1S SOLOTRAK W/SN 8FR |
| 00721902577161 | PLI 6207BTK1S SOLOTRAK W/SN 7FR |
Trademark Results [SOLO-TRAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLO-TRAK 74176693 1763650 Live/Registered |
Medtronic, Inc. 1991-06-17 |
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