NA

Basic Information

• Brand Name: NA
• Primary DI: 00613994258250
• Version / Model: ACS500
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-19
• Public Version: 4
• Public Version Date: 2020-06-05
• Public Version Status: Update
• Public Device Record Key: c7f4cb9b-3bdc-43d9-b5fa-4e99bd4a3162

Device Description

SYSTEM ACS500 AUTOCLAMP

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWA	Control, pump speed, cardiopulmonary bypass	Cardiovascular	870.4380	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32146	Medical tubing clip/clamp, temporary, non-calibrated, reusable	A non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994258250	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K070286	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Atmospheric Limitation of 700 hPa to 1060 hPa
• Type: Storage Environment Temperature
• Temperature Range: -40 – 66 Degrees Celsius