COUGAR® XT

GUDID 00643169452794

GDWR CGRXT300HJ COUGARXT 5PK 300 J HY

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00643169452794
• NIH Device Record Key: a847c0dd-adfd-499b-aeb6-2615d19771a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COUGAR® XT
• Version Model Number: CGRXT300HJ
• 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

• Length: 300 Centimeter
• Length: 300 Centimeter
• Length: 300 Centimeter
• Length: 300 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169452794 [Primary]
GS1	20643169452798 [Package]; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140695

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: 2018-07-06
• Device Publish Date: 2016-07-03

On-Brand Devices [COUGAR® XT]

• 20643169453320: GDWR CGRXT190HS COUGARXT 5PK 190 ST HY
• 20643169453306: GDWR LVCXT190S COUGRXT CRM 5PK 190 ST HY
• 20643169453290: GDWR LVCXT190J COUGARXT CRM 5PK 190 J HY
• 20643169453269: GDWR CGRXT300S COUGARXT 5PK 300 ST SIL
• 20643169452828: GDWR CGRXT190HJ COUGARXT 5PK 190 J HY
• 00643169452817: GDWR CGRXT190J COUGARXT 5PK 190 J SIL
• 20643169452804: GDWR CGRXT190S COUGARXT 5PK 190 ST SIL
• 00643169452794: GDWR CGRXT300HJ COUGARXT 5PK 300 J HY
• 20643169452781: GDWR CGRXT300HS COUGARXT 5PK 300 ST HY
• 20643169452774: GDWR CGRXT300J COGARXT 5PK 300 J SIL
• 20763000570136: GDWR CGRXT190HS COUGARXT 5PK 190 ST HY
• 20763000570112: GDWR CGRXT300S COUGARXT 5PK 300 ST SIL
• 20763000570037: GDWR CGRXT190HJ COUGARXT 5PK 190 J HY
• 20763000570020: GDWR CGRXT190J COUGARXT 5PK 190 J SIL
• 20763000570013: GDWR CGRXT190S COUGARXT 5PK 190 ST SIL
• 20763000570006: GDWR CGRXT300HJ COUGARXT 5PK 300 J HY
• 20763000569994: GDWR CGRXT300HS COUGARXT 5PK 300 ST HY
• 20763000569987: GDWR CGRXT300J COGARXT 5PK 300 J SIL