GUDID 00643169838529

BP CUFF CONTOUR LARGE BP-D03

Medtronic Care Management Services, LLC

Blood pressure cuff, reusable Blood pressure cuff, reusable

• Primary Device ID: 00643169838529
• NIH Device Record Key: 8359e1b4-d215-4c4a-b25b-45d2a4c52a62
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 450001-016
• Company DUNS: 061079989
• Company Name: Medtronic Care Management Services, LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169838529 [Primary]

FDA Product Code

• DXN: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-08

Devices Manufactured by Medtronic Care Management Services, LLC

• 00643169838482 - NA: 2019-07-22 BP CUFF REGULAR SMALL BP-D01
• 00643169838499 - NA: 2019-07-22 BP CUFF REGULAR MEDIUM BP-D02
• 00643169838505 - NA: 2019-07-22 BP CUFF REGULAR LARGE BP-D03
• 00643169838512 - NA: 2019-07-22 BP CUFF CONTOUR MEDIUM BP-D02
• 00643169838529 - NA: 2019-07-22BP CUFF CONTOUR LARGE BP-D03
• 00643169838529 - NA: 2019-07-22 BP CUFF CONTOUR LARGE BP-D03
• 00763000286972 - Commander Flex™: 2019-07-16 HUB CD320 CMDR FLEX - GA
• 00763000286989 - Commander Flex™: 2019-07-16 HUB CD320 CMDR FLEX - CA
• 00763000286996 - Commander Flex™: 2019-07-16 HUB CD320 CMDR FLEX - CV