Z-6™ 611050

GUDID 04046955718047

Z695 ATRIO BALLOON CATHETER 9.5MM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac septostomy catheter, balloon

• Primary Device ID: 04046955718047
• NIH Device Record Key: a6c6c34a-82ab-4754-a6e5-dcfa5b660091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-6™
• Version Model Number: 611050
• Catalog Number: 611050
• Company DUNS: 784259751
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, 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: 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

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 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 20 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955718047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211910

FDA Product Code

• DXF: CATHETER, SEPTOSTOMY

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: 2021-09-13
• Device Publish Date: 2021-09-04

On-Brand Devices [Z-6™]

• 04046955718054: Z6135 ATRIO BALLOON CATHETER 13.5MM
• 04046955718047: Z695 ATRIO BALLOON CATHETER 9.5MM