Easy BAL Clip™ 41010000

GUDID 03664977000011

The Easy BAL Clip™ is a non-sterile, single-use device designed as an add-on to the Broncoflex™ during a Broncho Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure. The Easy BAL Clip™ consists of two main components: a body able to be attached on the Broncoflex™ endoscope and a screw able to maintain a suction trap straight and upward with no kink of the suction line The Easy BAL Clip™ is supplied ready to be used in a plastic zip bag. Easy BAL Clip™ devices are packed in boxes of 10.

AXESS VISION TECHNOLOGY

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• Primary Device ID: 03664977000011
• NIH Device Record Key: 56c7a921-2b9e-4f61-b2cb-1a06f4801560
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy BAL Clip™
• Version Model Number: 41010000
• Catalog Number: 41010000
• Company DUNS: 285985615
• Company Name: AXESS VISION TECHNOLOGY
• Device Count: 10
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com
• Phone: +330247343290
• Email: info.endovision@tsc-group.com

Device Dimensions

• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram
• Height: 30 Millimeter
• Width: 75 Millimeter
• Length: 90 Millimeter
• Weight: 15.5 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664977000011 [Unit of Use]
GS1	03664977000042 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

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: 2023-08-07
• Device Publish Date: 2023-07-28

Devices Manufactured by AXESS VISION TECHNOLOGY

• 03664977000011 - Easy BAL Clip™: 2023-08-07The Easy BAL Clip™ is a non-sterile, single-use device designed as an add-on to the Broncoflex™ during a Broncho Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure. The Easy BAL Clip™ consists of two main components: a body able to be attached on the Broncoflex™ endoscope and a screw able to maintain a suction trap straight and upward with no kink of the suction line The Easy BAL Clip™ is supplied ready to be used in a plastic zip bag. Easy BAL Clip™ devices are packed in boxes of 10.
• 03664977000011 - Easy BAL Clip™: 2023-08-07 The Easy BAL Clip™ is a non-sterile, single-use device designed as an add-on to the Broncoflex™ during a Broncho Alveolar La
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