Z-5™ 611100

GUDID 04046964333439

SPT003 ANGIO BALLOON 13.5, 1.35

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon Cardiac septostomy catheter, balloon

• Primary Device ID: 04046964333439
• NIH Device Record Key: bce6b7f8-a257-4973-b0e5-1b8282cc1694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-5™
• Version Model Number: 611100
• Catalog Number: 611100
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964333439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960070

FDA Product Code

• DXF: CATHETER, SEPTOSTOMY

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: 2022-11-02
• Device Publish Date: 2016-08-09

On-Brand Devices [Z-5™]

• 04046964333811: SPT-002 SEPTOSTOMY 9.5 ST., .95
• 04046964333439: SPT003 ANGIO BALLOON 13.5, 1.35