COEfficient™ 611241
GUDID 04046964334627
COE146 COEFFICIENT BALLOON 8 X 4 X 135
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter| Primary Device ID | 04046964334627 |
| NIH Device Record Key | cd7d4d80-8e10-4959-9046-2bc60cdba01b |
| Commercial Distribution Discontinuation | 2021-08-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | COEfficient™ |
| Version Model Number | 611241 |
| Catalog Number | 611241 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964334627 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K014124
FDA Product Code
| MAD | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
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 | 2021-08-06 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [COEfficient™]
| 04046964334504 | COE140 COEFFICIENT BALLOON 5 X 4 X 135 |
| 04046964334467 | COE138 COEFFICIENT BALLOON 4 X 4 X 135 |
| 04046964334771 | COE154 COEFFICIENT BALLOON 12 X 4 X 135 |
| 04046964334740 | COE152 COEFFICIENT BALLOON 11 X 4 X 135 |
| 04046964334696 | COE150 COEFFICIENT BALLOON 10 X 4 X 135 |
| 04046964334665 | COE148 COEFFICIENT BALLOON 9 X 4 X 135 |
| 04046964334634 | COE147 COEFFICIENT BALLOON 9 X 3 X 135 |
| 04046964334627 | COE146 COEFFICIENT BALLOON 8 X 4 X 135 |
| 04046964334580 | COE144 COEFFICIENT BALLOON 7 X 4 X 135 |
| 04046964334559 | COE143 COEFFICIENT BALLOON 7 X 3 X 135 |
| 04046964334542 | COE142 COEFFICIENT BALLOON 6 X 4 X 135 |
| 04046964334528 | COE141 COEFFICIENT BALLOON 6 X 3 X 135 |
| 04046964334481 | COE139 COEFFICIENT BALLOON 5 X 3 X 135 |
| 04046964334443 | COE137 COEFFICIENT BALLOON 4 X 3 X 135 |
| 04046964336324 | COE132 BALLOON CATHETER |
| 04046964336300 | COE131 BALLOON CATHETER |
| 04046964336287 | COE130 BALLOON CATHETER |
| 04046964336263 | COE129 BALLOON CATHETER |
| 04046964336249 | COE128 BALLOON CATHETER |
| 04046964334757 | COE153 COEFFICIENT BALLOON 12 X 3 X 135 |
| 04046964334726 | COE151 COEFFICIENT BALLOON 11 X 3 X 135 |
| 04046964334689 | COE149 COEFFICIENT BALLOON 10 X 3 X 135 |
| 04046964334603 | COE145 COEFFICIENT BALLOON 8 X 3 X 135 |
| 04046964334429 | COE136 COEFFICIENT BALLOON 12 X 2 |
| 04046964334405 | COE135 COEFFICIENT BALLOON 11 X 2 |
| 04046964334375 | COE134 COEFFICIENT BALLOON 10MM X 2CM |
| 04046964334368 | COE133 COEFFICIENT BALLOON 9MM X 2CM |
| 04046964334344 | COE127 COEFFICIENT BALL 12MM X 4CM |
| 04046964334320 | COE126 COEFFICIENT BALL 12MM X 3CM |
| 04046964334306 | COE125 COEFFICIENT BALL 12MM X 2CM |
| 04046964334283 | COE124 COEFFICIENT BALL 11MM X 4CM |
| 04046964334269 | COE123 COEFFICIENT BALL 11MM X 3CM |
| 04046964334245 | COE122 COEFFICIENT BALL 11MM X 2CM |
| 04046964334221 | COE121 COEFFICIENT BALL 10MM X 4CM |
| 04046964334207 | COE120 COEFFICIENT BALL 10MM X 3CM |
| 04046964334184 | COE119 COEFFICIENT BALL 10MM X 2CM |
| 04046964334160 | COE118 COEFFICIENT BALL 9MM X 4CM |
| 04046964334153 | COE117 COEFFICIENT BALL 9MM X 3CM |
| 04046964334122 | COE116 COEFFICIENT BALL 9MM X 2CM |
| 04046964334108 | COE115 COEFFICIENT BALL 8MM X 4CM |
| 04046964334085 | COE114 COEFFICIENT BALL 8MM X 3CM |
| 04046964334078 | COE113 COEFFICIENT BALL 8MM X 2CM |
| 04046964334047 | COE112 COEFFICIENT BALL 7MM X 4CM |
| 04046964334023 | COE111 COEFFICIENT BALL 7MM X 3CM |
| 04046964334016 | COE110 COEFFICIENT BALL 7MM X 2CM |
| 04046964333996 | COE109 COEFFICIENT BALL 6MM X 4CM |
| 04046964333965 | COE108 COEFFICIENT BALL 6MM X 3CM |
| 04046964333941 | COE107 COEFFICIENT BALL 6MM X 2CM |
| 04046964333934 | COE106 COEFFICIENT BALL 5MM X 4CM |
| 04046964333903 | COE105 COEFFICIENT BALL 5MM X 3CM |
Trademark Results [COEfficient]
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