AN20 - Andersen Long Non-Mercury Weighted Sump Tub

GUDID 05060171440543

AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Case 50 Ct.)

ANDERSEN PRODUCTS, INC.

Nasogastric/orogastric tube

• Primary Device ID: 05060171440543
• NIH Device Record Key: d8a13d4c-e0fb-4ac4-a071-32be40f192a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN20 - Andersen Long Non-Mercury Weighted Sump Tub
• Version Model Number: AN20.00
• Company DUNS: 041867342
• Company Name: ANDERSEN PRODUCTS, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060171440543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011077

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: 2018-07-06
• Device Publish Date: 2017-01-25

On-Brand Devices [AN20 - Andersen Long Non-Mercury Weighted Sump Tub]

• 05060171440550: AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Overpack 250 Ct.)
• 05060171440543: AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Case 50 Ct.)
• 05060171440536: AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Box 10 Ct.)
• 05060171440345: AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Individual)