AccessGUDID - DEVICE: Easy BAL Clip™ (03664977000042)

GUDID

Device Identifier (DI) Information

Brand Name: Easy BAL Clip™
Version or Model: 41010000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41010000
Company Name: AXESS VISION TECHNOLOGY

Primary DI Number: 03664977000042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 285985615 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62137	Medical/surgical interventional tube/cable securement clip, single-use	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 30 Millimeter
Width: 75 Millimeter
Length: 90 Millimeter
Weight: 15.5 Gram

Device Record Status

Public Device Record Key: 56c7a921-2b9e-4f61-b2cb-1a06f4801560
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: July 28, 2023