Fixation Plate for AbbVie PEG 20 FR

GUDID 08054083004921

The saleable unit (device count) is 1, there are 5 fixation plates in the saleable unit

ABBVIE INC.

Gastrostomy tube

• Primary Device ID: 08054083004921
• NIH Device Record Key: bde1c6fc-dda6-4462-b7f2-4d925a30d6b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Plate for AbbVie PEG 20 FR
• Version Model Number: 62928
• 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	08054083004921 [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: false

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

Devices Manufactured by ABBVIE INC.

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• 38054083008173 - AbbVie Lightweight Vest XS: 2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
• 38054083008180 - AbbVie Lightweight Vest S: 2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
• 38054083008197 - AbbVie Lightweight Vest M: 2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
• 38054083008203 - AbbVie Lightweight Vest L: 2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
• 38054083008210 - AbbVie Lightweight Vest XL: 2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
• 38054083008227 - AbbVie Lightweight Vest XXL: 2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on