TubeClear 101-US

GUDID 00850458007010

ACTUATED MEDICAL, INC.

Enteral feeding/decompression tube clearing stem

• Primary Device ID: 00850458007010
• NIH Device Record Key: 9ebec681-32b5-494b-8e22-bda4086af1d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubeClear
• Version Model Number: Control Box Model 101
• Catalog Number: 101-US
• Company DUNS: 791379030
• Company Name: ACTUATED MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00850458007010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131052

FDA Product Code

• FPD: Tube, Feeding

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: 2018-07-06
• Device Publish Date: 2016-09-08

On-Brand Devices [TubeClear]

• 20850458007625: Clearing Stem
• 20850458007618: Clearing Stem
• 20850458007601: Clearing Stem
• 20850458007557: Clearing Stem
• 20850458007502: Clearing Stem
• 20850458007489: Clearing Stem
• 20850458007458: Clearing Stem
• 20850458007434: Clearing Stem
• 20850458007427: Clearing Stem
• 00850458007362: Clearing Stem
• 20850458007144: Clearing Stem
• 20850458007120: Clearing Stem
• 20850458007113: Clearing Stem
• 20850458007106: Clearing Stem
• 20850458007090: Clearing Stem
• 20850458007083: TubeClear
• 00850458007010: Control Box Model 101
• 00850458007003: TubeClear Clearing Stem for clearing clogs / occlusions in silicone AMT, MIC, and MIC-KEY gastro