LUMINELLE Aspirator 20081

GUDID 10853277008104

LUMINELLE Aspirator

UVISION 360, INC.

Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator Endocervical aspirator

• Primary Device ID: 10853277008104
• NIH Device Record Key: f10ff3ab-ae96-4a08-81a1-36f3c4790030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMINELLE Aspirator
• Version Model Number: LUM-A
• Catalog Number: 20081
• Company DUNS: 080826327
• Company Name: UVISION 360, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Fahrenheit and 60 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853277008107 [Primary]
GS1	10853277008104 [Package]; Contains: 00853277008107; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• QFZ: Gastroenterology-Urology Accessories To A Biopsy Instrument

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: 2024-03-08
• Device Publish Date: 2024-02-29

Devices Manufactured by UVISION 360, INC.

• 10853277008104 - LUMINELLE Aspirator: 2024-03-08LUMINELLE Aspirator
• 10853277008104 - LUMINELLE Aspirator: 2024-03-08 LUMINELLE Aspirator
• 10853277008081 - LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy): 2021-08-23 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
• 10853277008098 - LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy): 2021-08-23 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
• 00853277008060 - LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic): 2019-11-15 The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).
• 00853277008008 - LUMINELLE DTx 360 Rotatable Disposable Sheaths: 2019-11-05
• 00853277008015 - Uvision Hysteroscope: 2019-11-05
• 00853277008022 - Uvision Hysteroscope Cable: 2019-11-05
• 00853277008039 - Luminelle DTx Control Hub: 2019-11-05