TubeClear

Basic Information

• Brand Name: TubeClear
• Primary DI: 00850458007102
• Version / Model: G-1010
• Company Name: ACTUATED MEDICAL, INC.
• Labeler DUNS: 791379030
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7ee60ec4-4d1f-46ae-b39e-9c4452e7a870

Device Description

Clearing Stem

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPD	Tube, Feeding	Gastroenterology, Urology	876.5980	2
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59874	Endoscopic manual linear stapler	A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.	No	Active
58973	Enteral feeding/decompression tube clearing actuator	A mains electricity (AC-powered) device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. It is a reusable motorized unit that is magnetically coupled with a non-sterile, single-use, flexible clearing stem, placed in the tube, to actuate the stem clog disrupter (e.g., a wire or rod) and disrupt the obstruction. The actuator may contain internal replaceable or rechargeable batteries.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850458007106	GS1	Carton	10
Primary	00850458007102	GS1
Package	10850458007109	GS1	Carton	5

Premarket Submissions

Submission Number	Supplement Number
K131052	000