B.BRAUN 613400

GUDID 04046964310546

4F PICC SINGLE 50 NITGOLD 80 CTS450-NG80

B BRAUN INTERVENTIONAL SYSTEMS, INC

Peripherally-inserted central venous catheter

• Primary Device ID: 04046964310546
• NIH Device Record Key: 5840ba61-46ff-4035-a5de-f7e98343bfd9
• Commercial Distribution Discontinuation: 2016-07-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: B.BRAUN
• Version Model Number: 613400
• Catalog Number: 613400
• Company DUNS: 784259751
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
• 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

• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 4 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT.
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964310522 [Unit of Use]
GS1	04046964310546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083873

FDA Product Code

• LJS: Catheter,intravascular,therapeutic,long-term greater than 30 days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-25
• Device Publish Date: 2015-07-22

On-Brand Devices [B.BRAUN]

• 04046955308439: GUIDEWIRE, 018 X 300CM NIT/GOLD STRAIGHT
• 04046955308415: GUIDEWIRE, 018 X 300CM NIT/GOLD 15ANGLED
• 04046955308194: GUIDEWIRE, 018 X 180CM NIT/GOLD 15ANGLED
• 04046955308170: GUIDEWIRE, 018 X 80CM NIT/GOLD 15ANGLED
• 04046955300020: GUIDEWIRE, 018 X 180CM NIT/GOLD
• 04046955237463: GUIDEWIRE, .018 X 80CM NIT/GOLD
• 04046955237449: GUIDEWIRE, .018 X 60CM NIT/GOLD
• 04046955237425: GUIDEWIRE, .018 X 40CM NIT/GOLD
• 04046955237401: GUIDEWIRE, .018X 60CM SS/GOLD
• 04046964310881: 6F PICC TRIPLE 60 NITGLD130 CTT660-NG130
• 04046964310850: 6F PICC TRIPLE 60 NITGOLD 80 CTT660-NG80
• 04046964310812: 6F PICC DUAL 60 NITGLD130 CTD660-NG130
• 04046964310775: 5F PICC DUAL 55 NITGLD130 CTD555-NG130
• 04046964310737: 6F PICC DUAL 60 NITGOLD 80 CTD660-NG80
• 04046964310690: 5F PICC DUAL 55 NITGOLD 80 CTD555-NG80
• 04046964310669: 5F PICC SINGLE 55 NITGLD130 CTS555-NG130
• 04046964310621: 4F PICC SINGLE 50 NITGLD130 CTS450-NG130
• 04046964310584: 5F PICC SINGLE 55 NITGOLD 80 CTS555-NG80
• 04046964310546: 4F PICC SINGLE 50 NITGOLD 80 CTS450-NG80
• 04046963594749: CELSITE STL201L ST SET SIL 8,5F L IV USA