FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy BAL Clip™
DI: 03664977000042
·
Model: 41010000
·
AXESS VISION TECHNOLOGY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Easy BAL Clip™
- Primary DI
- 03664977000042
- Version / Model
- 41010000
- Catalog Number
- 41010000
- Company Name
- AXESS VISION TECHNOLOGY
- Labeler DUNS
- 285985615
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 1
- Public Version Date
- 2023-08-07
- Public Version Status
- New
- Public Device Record Key
- 56c7a921-2b9e-4f61-b2cb-1a06f4801560
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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) 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 03664977000011 | GS1 | ||||
| Primary | 03664977000042 | GS1 |
Customer Contacts
- Phone
- +330247343290
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 30 | Millimeter | |
| Width | 75 | Millimeter | |
| Length | 90 | Millimeter | |
| Weight | 15.5 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius