Pro-Flo XT™
GUDID 20613994942153
CATHETER 010371 PF 10PK 7F IMA ST XT
MEDTRONIC, INC.
Angiographic catheter, single-use| Primary Device ID | 20613994942153 |
| NIH Device Record Key | da9ae4cb-32eb-4e58-9269-99b8a7f9d318 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro-Flo XT™ |
| Version Model Number | 010371 |
| 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 |
Device Dimensions
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters in a cool, dry area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store catheters in a cool, dry area. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994942159 [Primary] |
| GS1 | 20613994942153 [Package] Contains: 00613994942159 Package: PK [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K960056
FDA Product Code
| DQO | CATHETER, INTRAVASCULAR, 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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-13 |
On-Brand Devices [Pro-Flo XT™]
| 20613994944607 | CATH 060051 PF 10PK 6F XT SF TP JL 4 125 |
| 20613994944584 | CATH 060049 PF 10PK6F XT PIG 145D 125 |
| 20613994944577 | CATH 060048 PF 10PK 6F XT PIG SF TP 125 |
| 20613994944089 | CATH 060038 PF 10PK6F SF TP XT AL III |
| 20613994944072 | CATH 060036 PF 10PK7F SF TP XT JL 4.5 |
| 20613994944041 | CATH 060033 PF 10PK6F SF TP XT JL 4.5 |
| 20613994944003 | CATH 060019 PF 10PK 6F XT 145 ANGLE TR P |
| 20613994943259 | CATH 06PX011 PF 5PK 6F XT MP A-2 110 SP |
| 20613994943242 | CATH 06PX008 PF 5PK6F XT STRAGHT PIG 110 |
| 20613994942931 | CATH 009235 PF 10PK 7F XT ST NO TORQUE R |
| 20613994942924 | CATH 009234 PF 10PK 6F XT ST NO TORQUE R |
| 20613994942917 | CATH 009231 PF 10PK 6 XT 100 MD AM RT ST |
| 20613994942825 | CATH 010244 PF 10PK 7F XT 145 PGTL 6 SH |
| 20613994942818 | CATHETER 010243 PF 10PK 7F XT PGTL 6 SH |
| 20613994942801 | CATH 010242 PF 10PK 6F XT 145 PGTL 6 SH |
| 20613994942795 | CATHETER 010241 PF 10PK 6F XT PGTL 6 SH |
| 20613994942764 | CATH 010214 PF 10PK 6F XT ARANI SF TP |
| 20613994942757 | CATHETER 010213 PF 6F XT ACTIVE |
| 20613994942740 | CATH 010212 PF 10PK 6F XT W/ST MP B-1 |
| 20613994942719 | CATH 010163 PF 10PK 7F XT JR6 SF TP 100 |
| 20613994942702 | CATH 010162 PF 10PK 7F XT JL6 SF TP 100 |
| 20613994942696 | CATH 010161 PF 10PK 6F XT JR6 SF TP 100 |
| 20613994942689 | CATH 010160 PF 10PK 6F XT JL6 SF TP 100 |
| 20613994942672 | CATH 010052 PF 10PK 7F XT MOD AMPL RT ST |
| 20613994942177 | CATH 010373 PF 10PK 7F XT SOFT TP MP A-2 |
| 20613994942160 | CATHETER 010372 PF 10PK 7F MP A-1 ST XT |
| 20613994942153 | CATHETER 010371 PF 10PK 7F IMA ST XT |
| 20613994942146 | CATH 010370 PF 10PK7F RIGHT BYPASS ST XT |
| 20613994942139 | CATH 010369 PF 10PK 7F LEFT BYPASS ST XT |
| 20613994942122 | CATHETER 010368 PF 10PK 7F AL II ST XT |
| 20613994942115 | CATHETER 010367 PF 10PK 7F AL I ST XT |
| 20613994942108 | CATHETER 010366 PF 10PK 7F AR II ST XT |
| 00613994942098 | CATHETER 010365 PF 10PK 7F AR I ST XT |
| 20613994942085 | CATHETER 010364 PF 10PK 7F JR 5 ST XT |
| 20613994942078 | CATHETER 010363 PF 10PK 7F JR 4 ST XT |
| 20613994942061 | CATHETER 010362 PF 10PK 7F JR 3.5 ST XT |
| 20613994942054 | CATHETER 010361 PF 10PK 7F ST JL 5 XT |
| 20613994942047 | CATHETER 010360 PF 10PK 7F ST JL 4 XT |
| 20613994942030 | CATHETER 010359 PF 10PK 7F ST JL 3.5 XT |
| 20613994942023 | CATHETER 010358 PF 10PK 7F MP A-2 XT |
| 20613994942009 | CATH 010356 PF 10PK 7F 145 PIGTAIL XT |
| 20613994941996 | CATH 010355 PF 10PK 7F 110 PIGTAIL XT |
| 20613994941606 | CATHETER 010248 PF 10PK 7F XT B-2 SFTP |
| 20613994941590 | CATHETER 010247 PF 10PK 7F XT B-1 SFTP |
| 00613994941565 | CATH 010354 PF 10PK 6F 110 MP A2 ST XT |
| 20613994941552 | CATH 010353 PF 10PK 6F 100 MP A1 ST XT |
| 20613994941545 | CATH 010352 PF 10PK 6F 100 IMA ST XT |
| 20613994941538 | CATH 010351 PF 10PK 6F 100 R BYP ST XT |
| 00613994941527 | CATH 010350 PF 10PK 6F 100 L BYP ST XT |
| 20613994941507 | CATH 010348 PF 10PK 6F 100 AL I ST XT |
Trademark Results [Pro-Flo XT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-FLO XT 86592123 4917916 Live/Registered |
Edelbrock, LLC 2015-04-09 |
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