GUDID 00613994258250

SYSTEM ACS500 AUTOCLAMP

MEDTRONIC, INC.

Medical tubing clip/clamp, non-calibrated, reusable

• Primary Device ID: 00613994258250
• NIH Device Record Key: c7f4cb9b-3bdc-43d9-b5fa-4e99bd4a3162
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ACS500
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 66 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994258250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070286

FDA Product Code

• DWA: Control, pump speed, cardiopulmonary bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-19

Devices Manufactured by MEDTRONIC, INC.

• 00643169955653 - N'VISION®: 2024-10-14 SOFTWARE 8870AAV01 N'VISION US
• 00763000974732 - NA: 2024-10-14 CUSTOM PACK BB12H94R UNC 3/16 AV LP
• 00763000978297 - NA: 2024-10-14 CUSTOM PACK BB11F30R2 ADULTRES
• 00763000978303 - NA: 2024-10-14 CUSTOM PACK 3Y90R11 NURSES
• 00763000978426 - NA: 2024-10-14 CUSTOM PACK BB11C01R9 CHILD PACK
• 00763000978549 - NA: 2024-10-14 CUSTOM PACK BB12F68R6 SPECIALTY CAR
• 00763000978648 - NA: 2024-10-14 CUSTOM PACK BB2G71R11 ST. AGNES PK
• 00763000979119 - NA: 2024-10-14 CUSTOM PACK BB8P50R4 SUPPORT