AddWire™ H74922150010

GUDID 08714729315933

Lake Region Medical

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 08714729315933
• NIH Device Record Key: 0e992f11-14bd-41ff-b1af-5e4641e686e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AddWire™
• Version Model Number: H74922150010
• Catalog Number: H74922150010
• Company DUNS: 031108704
• Company Name: Lake Region Medical
• 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

Device Dimensions

• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 145 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729315933 [Primary]
GS1	08714729315940 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011968

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: 4
• Public Version Date: 2024-06-26
• Device Publish Date: 2016-10-31

Devices Manufactured by Lake Region Medical

• 08714729761761 - ZIPwire™: 2024-06-28
• 08714729761778 - ZIPwire™: 2024-06-28
• 08714729761785 - ZIPwire™: 2024-06-28
• 08714729761792 - ZIPwire™: 2024-06-28
• 08714729761808 - ZIPwire™: 2024-06-28
• 08714729755333 - ZIPwire™: 2024-06-28
• 08714729755326 - ZIPwire™: 2024-06-28
• 08714729802433 - ZIPwire™: 2024-06-28