INDURA ® 1P

GUDID 00643169158092

CATH 8709SC SUTERLESS CONN UPDATE JUNCOS

MEDTRONIC, INC.

General-purpose implantable infusion pump, programmable

• Primary Device ID: 00643169158092
• NIH Device Record Key: 96ad4d58-904a-4bfb-823c-a89005a2bde7
• Commercial Distribution Discontinuation: 2017-03-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INDURA ® 1P
• Version Model Number: 8709SC
• Company DUNS: 796986144
• 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169158092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860004

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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: 2016-04-27

Devices Manufactured by MEDTRONIC, INC.

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• 00199150062027 - NA: 2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK
• 20199150062229 - NA: 2025-12-08 CUSTOM PACK BB1Q47R3 5PK ACC TABLE
• 20199150062243 - NA: 2025-12-08 CUSTOM PACK BB12R66R 20PK ACC 1/4 W/LL
• 20199150062960 - NA: 2025-12-08 CUSTOM PACK BB9R13R15 4PK CPN PLEG PACK
• 00643169265691 - NA: 2025-12-08 LEAD ACC KIT 6056M GLOBAL 17L NEW ACI
• 00199150060467 - NA: 2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC
• 00199150060627 - NA: 2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS