Pro-Flo XT™

GUDID 20613994941491

CATH 010347 PF 10PK 6F 100 AR II ST XT

MEDTRONIC, INC.

Angiographic catheter, single-use

• Primary Device ID: 20613994941491
• NIH Device Record Key: dee31533-f51a-4a69-afab-3f41ffae3452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Flo XT™
• Version Model Number: 010347
• 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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

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	00613994941497 [Primary]
GS1	20613994941491 [Package]; Contains: 00613994941497; 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