DiamondTemp™ Bidirectional Ablation Catheter
GUDID 00763000482121
CATH CEDTB300S BIDIR SM CURVE US
MEDTRONIC, INC.
Cardiac radio-frequency ablation system catheter| Primary Device ID | 00763000482121 |
| NIH Device Record Key | ad0ec1a7-cc27-45af-8459-d576ab867c87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DiamondTemp™ Bidirectional Ablation Catheter |
| Version Model Number | CEDTB300S |
| 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 | false |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 |
| Tip Bend Radius | 45 Millimeter |
| Outer Diameter | 2.67 Millimeter |
| Catheter Length | 110 Centimeter |
| 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000482121 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P200028
FDA Product Code
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
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 | 2021-10-29 |
| Device Publish Date | 2021-10-21 |
On-Brand Devices [DiamondTemp™ Bidirectional Ablation Catheter]
| 00763000482138 | CATH CEDTB400L BIDIR LG CURVE US |
| 00763000482121 | CATH CEDTB300S BIDIR SM CURVE US |
| 00763000747121 | CATH CEDTB400L BIDIR LG CURVE US 2Y |
| 00763000747114 | CATH CEDTB300S BIDIR SM CURVE US 2Y |
| 00763000536688 | BIDIR CATH SM CURVE CEDTB300S US |
| 00763000536671 | BIDIR CATH LG CURVE CEDTB400L US |
Trademark Results [DiamondTemp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIAMONDTEMP 87036983 5950458 Live/Registered |
EPIX THERAPEUTICS, INC. 2016-05-13 |
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