CardioMEMS™ CM2010

GUDID 15414734509562

0.018 in / 260 cm

CARDIOMEMS, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 15414734509562
• NIH Device Record Key: 856398c9-b438-4a22-93df-e26fc809750f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioMEMS™
• Version Model Number: Guidewire
• Catalog Number: CM2010
• Company DUNS: 086938409
• Company Name: CARDIOMEMS, 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: true
• Expiration Date: true
• 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(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 0.018 Inch
• Length: 260 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734509565 [Primary]
GS1	15414734509562 [Package]; Contains: 05414734509565; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

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: 2018-04-05
• Device Publish Date: 2015-07-15

On-Brand Devices [CardioMEMS™]

• 05415067029331: Hospital Electronics System
• 05414734509800: Patient Electronics System
• 15414734509562: 0.018 in / 260 cm
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• 05414734509237: PA Sensor and Delivery System
• 05414734509176: CM1010
• 05414734509169: CM1000
• 05414734509398: WiFi Adaptor
• 05414734509299: US Power Cord-110V
• 05414734509220: Electronics Travel Case