FDA.reportPublic FDA data

Easy BAL Clip™

Primary DI
03664977000042
Brand
Easy BAL Clip™
Company
AXESS VISION TECHNOLOGY
Model
41010000
Catalog number
41010000
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.
Published
2023-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664977000042PrimaryGS10
03664977000011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664977000042036649770000423664977000042
03664977000011036649770000113664977000011

GMDN Terms#

Term, Definition table
TermDefinition
Medical/surgical interventional tube/cable securement clip, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height30Millimeter
Length90Millimeter
Weight15.5Gram
Width75Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+330247343290info.endovision@tsc-group.com

Regulatory Flags#

DUNS number
285985615
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664977000103Broncoflex XFlo100400012025-07-18
03664977000011Easy BAL Clip™41010000410100002023-07-28
03664977010034Broncoflex Vortex10030001100300012020-12-10
03664977020033Broncoflex Agile20030001200300012020-12-10
03664977030032Screeni30030001300300012020-12-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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