AbbVie J

GUDID 08054083014432

The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit (List Number 62918-001) AbbVie J Tube for 20 FR PEG kit (List Number 0AV062-001) This kit includes (Fig. 1): - AbbVie J Tube with Teflon coated Guide Wire and Blue Guide Wire Lock - Y-Connector for the 15 FR PEG or 20 FR PEG - Fixation Screw (blue: 15 FR or violet: 20 FR) with Outer Ring - Click Adaptor consisting of: - Click Adaptor Cap - Click Adaptor Connector

ABBVIE INC.

Jejunostomy tube

• Primary Device ID: 08054083014432
• NIH Device Record Key: 96f3f023-6a8b-4bba-9ee1-cc03efa0ed3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AbbVie J
• Version Model Number: AV062
• Company DUNS: 078458370
• Company Name: ABBVIE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054083014432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142816

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-04-15

On-Brand Devices [AbbVie J]

• 08054083014432: The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit
• 08054083004860: The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit