PTS® 613705

GUDID 04046964311017

PTS403 PTS BALLOON 40MM X 3CM X 80CM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter

• Primary Device ID: 04046964311017
• NIH Device Record Key: 56b87909-7557-4721-8aec-4b49edac4150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTS®
• Version Model Number: 613705
• Catalog Number: 613705
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964311017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003320

FDA Product Code

• MJN: Catheter, intravascular occluding, temporary

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 [PTS®]

• 04046964311055: PTS405 PTS BALLOON 40MM X 5CM X 80CM
• 04046964311031: PTS404 PTS BALLOON 40MM X 4CM X 80CM
• 04046964311017: PTS403 PTS BALLOON 40MM X 3CM X 80CM
• 04046964310997: PTS305 PTS BALLOON 30MM X 5CM X 80 CM
• 04046964310973: PTS304 PTS BALLOON 30MM X 4CM X 80CM
• 04046964310959: PTS303 PTS BALLOON 30MM X 3CM X 80CM
• 04046964310935: PTS253 PTS BALLOON 25MM X 3CM X 80CM
• 04046964310911: PTS203 PTS BALLOON 20MM X 3CM X 80CM