TubeClear GJ-1422

GUDID 00850458007003

TubeClear Clearing Stem for clearing clogs / occlusions in silicone AMT, MIC, and MIC-KEY gastro-jejunostomy tubes size 14-22 Fr.

ACTUATED MEDICAL, INC.

Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator Enteral feeding/decompression tube clearing actuator

• Primary Device ID: 00850458007003
• NIH Device Record Key: a74270e4-c695-46a2-a381-91a7ea42c22b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubeClear
• Version Model Number: GJ-1422
• Catalog Number: GJ-1422
• Company DUNS: 791379030
• Company Name: ACTUATED MEDICAL, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850458007003 [Primary]
GS1	10850458007000 [Package]; Package: Carton [5 Units]; In Commercial Distribution
GS1	20850458007007 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200646

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-11
• Device Publish Date: 2021-01-01

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• 00850458007003: TubeClear Clearing Stem for clearing clogs / occlusions in silicone AMT, MIC, and MIC-KEY gastro