EVEREST™

GUDID 00643169843028

SURVIVAL KIT AC2205P EVEREST 20 TJM

MEDTRONIC, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00643169843028
• NIH Device Record Key: f4fd0e45-ed8d-452f-b579-5e3d8c87136f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVEREST™
• Version Model Number: AC2205P
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store accessories in a clean, cool and dark area.
• Special Storage Condition, Specify: Between 0 and 0 *Store accessories in a clean, cool and dark area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169843028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153038

FDA Product Code

• MAV: Syringe, balloon inflation

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: 2020-05-06
• Device Publish Date: 2018-07-06

On-Brand Devices [EVEREST™]

• 00643169014817: SURVIVAL KIT AC3205P EVEREST 30 TJM
• 00643169014800: INFLATION DEV AC3200 EVEREST 30 TJM
• 00643169014794: SURVIVAL KIT AC2205P EVEREST 20 TJM
• 00643169014787: INFLATION DEV AC2200 EVEREST 20 TJM
• 00643169843042: SURVIVAL KIT AC3205P EVEREST 30 TJM
• 00643169843035: INFLATION DEV AC3200 EVEREST 30 TJM
• 00643169843028: SURVIVAL KIT AC2205P EVEREST 20 TJM
• 00643169843011: INFLATION DEV AC2200 EVEREST 20 TJM
• 00643169621923: SURVIVAL KIT AC3205P EVEREST 30 TJM
• 00643169621916: INFLATION DEV AC3200 EVEREST 30 TJM
• 00643169621909: SURVIVAL KIT AC2205P EVEREST 20 TJM
• 00643169621893: INFLATION DEV AC2200 EVEREST 20 TJM