DLP™

GUDID 00763000192983

CANN CB80120 ART MTL TIP 20FR

MEDTRONIC, INC.

Cardiopulmonary bypass cannula, arterial

• Primary Device ID: 00763000192983
• NIH Device Record Key: 8614ce77-864c-4bdc-afac-5e83aab64a8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DLP™
• Version Model Number: CB80120
• 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: true
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000192983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K840002

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-14
• Device Publish Date: 2019-03-06

On-Brand Devices [DLP™]

• 00643169969285: SUCTION CB12008 LV VENT 10FR PVC 17L
• 00643169767683: SET MULTIPLE PERFUSION CB14017 DLP
• 00643169767676: CAN CB10005 DLP ADAPT Y VENTNG 1B
• 00643169697577: CANNULA CB57421 FEM ART 21FR
• 00643169697560: CANNULA CB57417 FEM ART 17FR
• 00643169697539: CANN CB69428 VEN RT MTL 28F 17
• 00643169697522: CANN CB69331 VEN RT MTL 31F 17
• 00643169697515: CANN CB69328 VEN RT MTL 28F 17
• 00643169697508: CANN CB69324 VEN RT MTL 24F 17
• 00643169697492: CANN CB69322 VEN RT MTL 22F 17
• 00643169697485: CANN CB69320 VEN RT MTL 20F 17
• 00643169697478: CANN CB68140 SS VEN MAL 40F 17
• 00643169697461: CANN CB68138 SS VEN MAL 38F 17
• 00643169697454: CANN CB68136 SS VEN MAL 36F 17
• 00643169697447: CANN CB68134 SS VEN MAL 34F 17
• 00643169697430: CANN CB68132 SS VEN MALL 32FR 17L
• 00643169697423: CANN CB68130 SS VEN MAL 30F 17
• 00643169697416: CANN CB68128 SS VEN MAL 28F 17
• 00643169697409: CANN CB68126 SS VEN MAL 26F 17
• 00643169697393: CANN CB68124 SS VEN MAL 24F 17
• 00643169697386: CANN CB68122 SS VEN MAL 22F 17
• 00643169697379: CANN CB68120 SS VEN MAL 20F 17
• 00643169697362: CANN CB68118 SS VEN MAL 18F 17
• 00643169697355: CANN CB68116 SS VEN MAL 16F 17
• 00643169697348: CANN CB68114 SS VEN MAL 14F 17
• 00643169697331: CANN CB68112 SS VEN MAL 12F 17
• 00643169697324: CANN CB67640 VEN RT PVC 40F 17
• 00643169697317: CANNULA CB67636 VEN RT PVC 36FR 17L
• 00643169697300: CANN CB67536 VEN RT PVC 36F 17
• 00643169697294: CANNULA CB67534 VEN RT PVC 34FR 17L
• 00643169697287: CANNULA CB67532 VEN RT PVC 32FR 17L
• 00643169697270: CANN CB67530 VEN RT PVC 30FR
• 00643169697263: CANN CB67528 VEN RT PVC 28F 17
• 00643169697256: CANNULA CB67524 VEN RT PVC 24FR 17L
• 00643169697249: CANN CB67522 VEN RT PVC 22F 17
• 00643169697232: CANN CB67520 VEN RT PVC 20F 17
• 00643169697225: CANN CB67518 VEN RT PVC 18F 17
• 00643169697218: CANN CB67516 VEN RT PVC 16F 17
• 00643169697201: CANN CB67514 VEN RT PVC 14F 17
• 00643169697195: CANN CB67512 VEN RT PVC 12F 17
• 00643169697188: CANN CB67320 VEN RT MTL 20F 17
• 00643169697171: CANN CB67318 VEN RT MTL 18F 17
• 00643169697164: CANN CB67316 VEN RT MET 16F 17
• 00643169697157: CANN CB67314 VEN RT MTL 14F 17
• 00643169697140: CANN CB67312 VEN RT MET 12FR
• 00643169697133: CANNULA CB66240 SS VENOUS 40FR 17L
• 00643169697126: CANN CB66236 SS VENOUS 36FR 17L
• 00643169697119: CANN CB66136 SS VEN 36FR 17L
• 00643169697102: CANN CB66134 SS VENOUS 34FR 17L
• 00643169697096: CANN CB66132 SS VEN 32FR 17L