AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Overpa

GUDID 05060171440635

AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Overpack 250 Ct.)

ANDERSEN PRODUCTS, INC.

Nasogastric/orogastric tube

• Primary Device ID: 05060171440635
• NIH Device Record Key: d1112930-07db-4785-b99a-aac49e697284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Overpa
• Version Model Number: AN10.05
• 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	05060171440635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935688

FDA Product Code

• BSS: Tube, Nasogastric

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

Devices Manufactured by ANDERSEN PRODUCTS, INC.

• 05060171440291 - Andersen Nasogastric Tube, 16 Fr.: 2018-07-06 Andersen Nasogastric Tube, 16 Fr. (Individual)
• 05060171440307 - AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr.,: 2018-07-06 AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Individual)
• 05060171440314 - AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr: 2018-07-06 AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Individual)
• 05060171440321 - AN11S - (11.11) - Andersen Nasogastric Tube, Pedia: 2018-07-06 AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (Individual)
• 05060171440338 - AN11.50 - Andersen Nasogastric Tube, Pediatric, 10: 2018-07-06 AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Individual)
• 05060171440345 - AN20 - Andersen Long Non-Mercury Weighted Sump Tub: 2018-07-06 AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Individual)
• 05060171440352 - AN22 - Andersen Miller-Abbott Type Intestinal Tube: 2018-07-06 AN22 - Andersen Miller-Abbott Type Intestinal Tube, 16 Fr., Pre-Weighted (Individual)
• 05060171440383 - AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 C: 2018-07-06 AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 Ct.)