PTS® 613707

GUDID 04046964311055

PTS405 PTS BALLOON 40MM X 5CM X 80CM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac sizing catheter

• Primary Device ID: 04046964311055
• NIH Device Record Key: 2715ac57-9574-4a16-b70c-0a6c974eee33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTS®
• Version Model Number: 613707
• Catalog Number: 613707
• 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 *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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964311055 [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