| 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 |
| 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 |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 03664977000011 [Unit of Use] |
| GS1 | 03664977000042 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-07 |
| Device Publish Date | 2023-07-28 |
| 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 |
| 03664977010034 - Broncoflex Vortex | 2020-12-18 Broncoflex Vortex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reu |
| 03664977020033 - Broncoflex Agile | 2020-12-18 Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reus |
| 03664977030032 - Screeni | 2020-12-18 Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display li |