MAJ-1727 OBCU RESERVOIR TANK

MAJ
RESERVOIR TANK - MAJ-1727

A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FED

Device Name: Endoscopic Access Overtube, Gastroenterology-Urology

Device Class: 2

Physical State: overtube

Definition: To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Endoscope inserted and advanced through center of device

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various openings in gi and gu tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: FDA

Device Name: Enteroscope And Accessories

Device Class: 2

Physical State: enteroscope and related accessories, may include balloon, mini-scope

Definition: To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: inserted through mouth or laparoscopically

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: small intestine

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: NWB

Device Name: Endoscope, Accessories, Narrow Band Spectrum

Device Class: 2

Physical State: The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display

Definition: Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optical filters or using light sources with inherently limited spectra such as lasers

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Limited to endoscopic systems for observation of the gastro-urological tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170239571

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A