DxTerity™

GUDID 20643169689613

CATH DXT5JL50X DXT 5F 5PK 125CM JL50

MEDTRONIC, INC.

Angiographic catheter, single-use

• Primary Device ID: 20643169689613
• NIH Device Record Key: 39f0ad3f-8d8a-4c12-b5b9-bb75039fd943
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxTerity™
• Version Model Number: DXT5JL50X
• 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: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light.
• Special Storage Condition, Specify: Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169689619 [Primary]
GS1	20643169689613 [Package]; Contains: 00643169689619; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161287

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: 2017-03-19

On-Brand Devices [DxTerity™]

• 20643169689682: CATH DXT5MPBSHA DXT 5F 5PK 110CM MPB
• 20643169689675: CATH DXT5MPBA DXT 5F 5PK 110CM MPB
• 20643169689668: CATH DXT5MPASHA DXT 5F 5PK 110CM MPA
• 20643169689651: CATH DXT5MPAA DXT 5F 5PK 110CM MPA
• 20643169689644: CATH DXT5JR50X DXT 5F 5PK 125CM JR50
• 20643169689637: CATH DXT5JR40X DXT 5F 5PK 125CM JR40
• 20643169689620: CATH DXT5JR35X DXT 5F 5PK 125CM JR35
• 20643169689613: CATH DXT5JL50X DXT 5F 5PK 125CM JL50
• 20643169689606: CATH DXT5JL45X DXT 5F 5PK 125CM JL45
• 20643169689590: CATH DXT5JL40X DXT 5F 5PK 125CM JL40
• 20643169689583: CATH DXT5PIGSTX DXT 5F 5PK 125CM PGSTR
• 20643169689576: CATH DXT5PIG55A DXT 5F 5PK 110CM PG155
• 20643169689569: CATH DXT5PIG45A DXT 5F 5PK 110CM PG145
• 20643169689552: CATH DXT5PIGSTA DXT 5F 5PK 110CM PGSTR
• 20643169689545: CATH DXT5IMA DXT 5F 5PK 100CM IMA
• 20643169689538: CATH DXT5LCB DXT 5F 5PK 100CM LCB
• 20643169689521: CATH DXT5RCB DXT 5F 5PK 100CM RCB
• 20643169689514: CATH DXT53DRC DXT 5F 5PK 100CM 3DRC
• 20643169689507: CATH DXT5NOTO DXT 5F 5PK 100CM NOTO
• 20643169689491: CATH DXT5MPBSH DXT 5F 5PK 100CM MPB
• 20643169689484: CATH DXT5MPB DXT 5F 5PK 100CM MPB
• 20643169689477: CATH DXT5MPASH DXT 5F 5PK 100CM MPA
• 20643169689460: CATH DXT5MPA DXT 5F 5PK 100CM MPA
• 20643169689453: CATH DXT5ARM DX 5F 5PK 100CM ARM
• 20643169689446: CATH DXT5AR20 DXT 5F 5PK 100CM AR20
• 20643169689439: CATH DXT5AR10 DXT 5F 5PK 100CM AR10
• 20643169689422: CATH DXT5AL30 DXT 5F 5PK 100CM AL30
• 20643169689415: CATH DXT5AL20 DXT 5F 5PK 100CM AL20
• 20643169689408: CATH DXT5AL10 DXT 5F 5PK 100CM AL10
• 20643169689392: CATH DXT5JR60 DXT 5F 5PK 100CM JR60
• 20643169689385: CATH DXT5JR50 DXT 5F 5PK 100CM JR50
• 20643169689378: CATH DXT5JR4M DXT 5F 5PK 100CM JR40M
• 20643169689361: CATH DXT5JR4ST DXT 5F 5PK 100CM JR4ST
• 20643169689354: CATH DXT5JR40 DXT 5F 5PK 100CM JR40
• 20643169689347: CATH DXT5JR35 DXT 5F 5PK 100CM JR35
• 20643169689330: CATH DXT5JL60 DXT 5F 5PK 100CM JL60
• 20643169689323: CATH DXT5JL50 DXT 5F 5PK 100CM JL50
• 20643169689316: CATH DXT5JL45 DXT 5F 5PK 100CM JL45
• 20643169689309: CATH DXT5JL40 DXT 5F 5PK 100CM JL40
• 20643169689293: CATH DXT5JL35 DXT 5F 5PK 100CM JL35
• 20643169689286: CATH DXT6MPBSHA DXT 6F 5PK 110CM MPB
• 20643169689279: CATH DXT6MPBA DXT 6F 5PK 110CM MPB
• 20643169689262: CATH DXT6MPASHA DXT 6F 5PK 110CM MPA
• 20643169689255: CATH DXT6MPAA DXT 6F 5PK 110CM MPA
• 20643169689248: CATH DXT6JR50X DXT 6F 5PK 125CM JR50
• 20643169689231: CATH DXT6JR40X DXT 6F 5PK 125CM JR40
• 20643169689224: CATH DXT6JR35X DXT 6F 5PK 125CM JR35
• 20643169689217: CATH DXT6JL50X DXT 6F 5PK 125CM JL50
• 20643169689200: CATH DXT6JL45X DXT 6F 5PK 125CM JL45
• 20643169689194: CATH DXT6JL40X DXT 6F 5PK 125CM JL40