CP Stent™ 614487

GUDID 04046955091607

MCP049 Mounted CP Stent 5 28 5.5 16F

B BRAUN INTERVENTIONAL SYSTEMS, INC

Bare-metal aortic stent

• Primary Device ID: 04046955091607
• NIH Device Record Key: be4be195-6574-4e45-a6ef-81ac710c7913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CP Stent™
• Version Model Number: 614487
• Catalog Number: 614487
• Company DUNS: 784259751
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955091607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150028

FDA Product Code

• PNF: Aortic stent

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: 2020-03-25
• Device Publish Date: 2017-12-23

On-Brand Devices [CP Stent™]

• 04046964901133: CMCP002 Mounted Covered CP Stent 1.6 14
• 04046964899676: CMCP038 Mounted Covered CP Stent 2.8 12
• 04046964899669: CMCP037 Mounted Covered CP Stent 4.5 12
• 04046964899652: CMCP036 Mounted Covered CP Stent 3.9 12
• 04046964899645: CMCP035 Mounted Covered CP Stent 3.4 12
• 04046964899638: CMCP034 Mounted Covered CP Stent 4.5 24
• 04046964899621: CMCP033 Mounted Covered CP Stent 4.5 22
• 04046964899614: CMCP032 Mounted Covered CP Stent 4.5 20
• 04046964899607: CMCP031 Mounted Covered CP Stent 4.5 18
• 04046964899591: CMCP030 Mounted Covered CP Stent 4.5 16
• 04046964899584: CMCP029 Mounted Covered CP Stent 4.5 14
• 04046964899577: CMCP028 Mounted Covered CP Stent 4.5 24
• 04046964899560: CMCP027 Mounted Covered CP Stent 4.5 22
• 04046964899553: CMCP026 Mounted Covered CP Stent 4.5 20
• 04046964899546: CMCP025 Mounted Covered CP Stent 4.5 18
• 04046964899539: CMCP024 Mounted Covered CP Stent 4.5 16
• 04046964899522: CMCP023 Mounted Covered CP Stent 4.5 14
• 04046964899515: CMCP022 Mounted Covered CP Stent 3.9 24
• 04046964899508: CMCP021 Mounted Covered CP Stent 3.9 22
• 04046964899492: CMCP020 Mounted Covered CP Stent 3.9 20
• 04046964899485: CMCP019 Mounted Covered CP Stent 3.9 18
• 04046964899478: CMCP018 Mounted Covered CP Stent 3.9 16
• 04046964899461: CMCP017 Mounted Covered CP Stent 3.9 14
• 04046964899454: CMCP016 Mounted Covered CP Stent 3.4 22
• 04046964899447: CMCP015 Mounted Covered CP Stent 3.4 20
• 04046964899430: CMCP014 Mounted Covered CP Stent 3.4 18
• 04046964899423: CMCP013 Mounted Covered CP Stent 3.4 16
• 04046964899416: CMCP012 Mounted Covered CP Stent 3.4 14
• 04046964899409: CMCP011 Mounted Covered CP Stent 2.8 20
• 04046964899393: CMCP010 Mounted Covered CP Stent 2.8 18
• 04046964899386: CMCP009 Mounted Covered CP Stent 2.8 16
• 04046964899379: CMCP008 Mounted Covered CP Stent 2.8 14
• 04046964899362: CMCP007 Mounted Covered CP Stent 2.2 18
• 04046964899355: CMCP006 Mounted Covered CP Stent 2.2 16
• 04046964899348: CMCP005 Mounted Covered CP Stent 2.2 14
• 04046964899331: CMCP004 Mounted Covered CP Stent 2.2 12
• 04046964899324: CMCP003 Mounted Covered CP Stent 1.6 16
• 04046964899317: CMCP001 Mounted Covered CP Stent 1.6 12
• 04046964899300: MCP038 Mounted CP Stent 2.8 12 3 8F
• 04046964899294: MCP037 Mounted CP Stent 4.5 12 5 8F
• 04046964899287: MCP036 Mounted CP Stent 3.9 12 4 8F
• 04046964899270: MCP035 Mounted CP Stent 3.4 12 3.5 8F
• 04046964899263: MCP034 Mounted CP Stent 4.5 24 5 9F
• 04046964899256: MCP033 Mounted CP Stent 4.5 22 5 9F
• 04046964899249: MCP032 Mounted CP Stent 4.5 20 5 9F
• 04046964899232: MCP031 Mounted CP Stent 4.5 18 5 9F
• 04046964899225: MCP030 Mounted CP Stent 4.5 16 5 9F
• 04046964899218: MCP029 Mounted CP Stent 4.5 14 5 8F
• 04046964899201: MCP028 Mounted CP Stent 4.5 24 4.5 9F
• 04046964899195: MCP027 Mounted CP Stent 4.5 22 4.5 9F