GUDID 20613994936237

CATH 5A0095 SS 5PK 5F ANG KIT W/3DRC 145

MEDTRONIC, INC.

Angiographic catheter, single-use Angiographic catheter, single-use

• Primary Device ID: 20613994936237
• NIH Device Record Key: 3efa36ef-2ace-4924-97a0-06da0825b6e0
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 5A0095
• 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

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	00613994936233 [Primary]
GS1	20613994936237 [Package]; Contains: 00613994936233; Package: PK [5 Units]; Discontinued: 2018-10-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932092

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: 4
• Public Version Date: 2019-01-30
• Device Publish Date: 2016-06-13

Devices Manufactured by MEDTRONIC, INC.

• 00763000943844 - NA: 2024-04-12 CUSTOM PACK BB11J59R5 PEDS
• 00763000943851 - NA: 2024-04-12 CUSTOM PACK BB12F35R3 A PACK
• 00763000943868 - NA: 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
• 00763000943899 - NA: 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD
• 00763000943882 - NA: 2024-04-12 CUSTOM PACK BB12C41R4 10PK LUNG PACK
• 00763000825539 - NA: 2024-04-08 REV KIT 8598A SPNL SGMNT CATH EMAN
• 00763000893491 - SHERPA NX BALANCED™: 2024-04-08 CATHETER SB6CHAMP05SH SB 6F 100CM CH05
• 20763000933412 - NA: 2024-04-08 CUSTOM PACK 12F60R 10PK VENTED SPIKE