AbbVie PEG

GUDID 08054083004952

The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp

ABBVIE INC.

Gastrostomy tube

• Primary Device ID: 08054083004952
• NIH Device Record Key: a1bd8ee0-72e5-4541-a9dc-37a3d9882656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AbbVie PEG
• Version Model Number: 62910
• Company DUNS: 078458370
• Company Name: ABBVIE 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054083004952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142793

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: 3
• Public Version Date: 2020-04-20
• Device Publish Date: 2019-04-15

On-Brand Devices [AbbVie PEG]

• 08054083004976: The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or
• 08054083004952: The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or