ACCEL® 613931

GUDID 04046955639069

ACCEL BILLIARY PD 8F 40CM W/MB AND LOCK

B BRAUN INTERVENTIONAL SYSTEMS, INC

Multi-purpose percutaneous abdominothoracic drainage catheter

• Primary Device ID: 04046955639069
• NIH Device Record Key: 161bcf85-b197-4595-b2b7-f0615fd24aec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCEL®
• Version Model Number: 613931
• Catalog Number: 613931
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046955639069 [Unit of Use]
GS1	04046955639076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210419

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

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: 2024-05-20
• Device Publish Date: 2024-05-12

On-Brand Devices [ACCEL®]

• 04046955323494: 600ML DRAI.BOTTLE,DR600LOCK,PVC-FREE,FPS
• 04046955237647: 3 PC INT, 21GAX15CM TROCAR
• 04046955237623: 3 PC INT, 22GAX15CM CHIBA
• 04046955237609: 3 PC INT, 018X60 SS-GOLD, 22GA CHIBA
• 04046955237586: 3 PC INT, 018X60 NIT-GOLD, 22GA CHIBA
• 04046955237562: 3 PC INT, 018X60 SS-GOLD, 21GA TROC
• 04046955237548: 3 PC, 018X60 NIT-GOLD, 038 GW, 21GA TROC
• 04046955237524: 3 PC, 018X60 SS-GOLD, 038 GW, 21GA TROC
• 04046955237500: 3 PC INT, 018X60 NIT-GOLD, 21GA TROC
• 04046955237487: HYDROPHILIC 6F 3 PIECE INTRODUCER
• 04046955237388: 22GA X 20CM CHIBA NEEDLE
• 04046955237364: 22GA X 15CM CHIBA NEEDLE
• 04046955237340: 21GA X 15CM TROCAR NEEDLE
• 04046955639304: ACCEL SECUREMENT DEVICE 12-18F
• 04046955639281: ACCEL SECUREMENT DEVICE 5-12F
• 04046955639205: ACCEL UNIVERSAL J-CURVED PD 12F 25CM
• 04046955639182: ACCEL UNIVERSAL J-CURVED PD 10F 25CM
• 04046955639168: ACCEL UNIVERSAL J-CURVED PD 8F 25CM
• 04046955639144: ACCEL CURVED J-TYPE PD 6F 20CM
• 04046955639120: ACCEL BILLIARY PD 14F 40CM W/MB AND LOCK
• 04046955639106: ACCEL BILLIARY PD 12F 40CM W/MB AND LOCK
• 04046955639083: ACCEL BILLIARY PD 10F 40CM W/MB AND LOCK
• 04046955639069: ACCEL BILLIARY PD 8F 40CM W/MB AND LOCK
• 04046955639045: ACCEL MINICLOSED LOOP PD 14F 25CM W/LOCK
• 04046955639021: ACCEL MINICLOSED LOOP PD 12F 25CM W/LOCK
• 04046955639007: ACCEL MINICLOSED LOOP PD 10F 25CM W/LOCK
• 04046955638987: ACCEL MINICLOSED LOOP PD 8F 25CM W/ LOCK
• 04046955638963: ACCEL MINICLOSED LOOP PD 7F 25CM W/LOCK
• 04046955638949: ACCEL MINICLOSED LOOP PD 12F 15CM W/LOCK
• 04046955638925: ACCEL MINICLOSED LOOP PD 10F 15CM W/LOCK
• 04046955638901: ACCEL MINICLOSED LOOP PD 8F 15CM W/ LOCK
• 04046955638888: ACCEL MINICLOSED LOOP PD 6F 15CM W/ LOCK
• 04046955638864: ACCEL MINICLOSED LOOP PD 7F 15CM
• 04046955638840: ACCEL MINICLOSED LOOP PD 6F 15CM
• 04046955638826: ACCEL MINICLOSED LOOP PD 5F 15CM
• 04046955638802: ACCEL APD 14F 40CM W/ MB AND LOCK
• 04046955638789: ACCEL APD 12F 40CM W/ MB AND LOCK
• 04046955638765: ACCEL APD 10F 40CM W/ MB AND LOCK
• 04046955638741: ACCEL APD 8F 40CM W/ MB AND LOCK
• 04046955638727: ACCEL APD 14F 35CM W/ LOCK
• 04046955638703: ACCEL APD 12F 35CM W/ LOCK
• 04046955638680: ACCEL APD 10F 35CM W/ LOCK
• 04046955638666: ACCEL APD 8F 35CM W/ LOCK
• 04046955638642: ACCEL APD 14F 25CM W/ MB AND LOCK
• 04046955638628: ACCEL APD 12F 25CM W/ MB AND LOCK
• 04046955638604: ACCEL APD 10F 25CM W/ MB AND LOCK
• 04046955638581: ACCEL APD 8F 25CM W/ MB AND LOCK
• 04046955638567: ACCEL APD 16F 25CM W/ LOCK
• 04046955638543: ACCEL APD 14F 25CM W/ LOCK
• 04046955638529: ACCEL APD 12F 25CM W/ LOCK