FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambu® aScope™ 5 Cysto HD
DI: 05707480164493
·
Model: 603101000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ambu® aScope™ 5 Cysto HD
- Primary DI
- 05707480164493
- Version / Model
- 603101000
- Catalog Number
- 603101000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-06
- Public Version
- 3
- Public Version Date
- 2025-11-26
- Public Version Status
- Update
- Public Device Record Key
- 50a3aa5d-f15d-48c0-9564-2345ed90cefb
Device Description
Flexible Cysto-nephroscope, Standard Deflection
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 67224 | Flexible video cystonephroscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, urethra (including prostate region), and kidneys. It is inserted into the urethra via the natural urinary orifice, or percutaneously into the renal pelvis for the kidneys during endoscopy. Anatomical images are obtained via a camera incorporated at its distal end and are shown on a monitor. It is typically used for the removal/crushing of stones, investigation of pyelitis and renal failure, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480164516 | GS1 | Case | 4 | In Commercial Distribution | |
| Package | 05707480164509 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 05707480164493 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 2.2 | Millimeter | |
| Outer Diameter | 6 | Millimeter |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius