FDA UDI
In Commercial Distribution
🇺🇸 United States
BubbleView®
DI: 06975339621209
·
Model: C50-CBR
·
MacroLux Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BubbleView®
- Primary DI
- 06975339621209
- Version / Model
- C50-CBR
- Company Name
- MacroLux Medical Technology Co., Ltd.
- Labeler DUNS
- 723490133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-10
- Public Version
- 2
- Public Version Date
- 2025-12-22
- Public Version Status
- Update
- Public Device Record Key
- 92280cf2-021f-46b2-b076-e4da091ffeac
Device Description
BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CBR
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61728 | Flexible video cystoscope, single-use | A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975339621206 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 06975339621209 | GS1 | ||||
| Package | 26975339621203 | GS1 | carton | 2 | In Commercial Distribution |