aScope™ 4 Cysto
- Primary DI
- 05707480157945
- Brand
- aScope™ 4 Cysto
- Company
- Ambu A/S
- Model
- 600177000
- Catalog number
- 600177000
- Device description
- aScope 4 Cysto - Reverse Deflection Bosma
- Published
- 2022-09-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
ambuusa.comProduct Codes
| Code | Name |
|---|---|
| FAJ | Cystoscope and accessories, flexible/rigid |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05707480157938 | Package | GS1 | 5 | In Commercial Distribution |
| 05707480157945 | Package | GS1 | 4 | In Commercial Distribution |
| 05707480157921 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05707480157938 | 05707480157938 | 5707480157938 |
| 05707480157945 | 05707480157945 | 5707480157945 |
| 05707480157921 | 05707480157921 | 5707480157921 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Length | 390 | Millimeter |
| Lumen/Inner Diameter | 2.2 | Millimeter |
| Outer Diameter | 6 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Humidity | 30 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +14107686464 | Purchase_orders@ambuUSA.com |
| +1(410)768-6464 | Purchase_orders@ambuUSA.com |
Regulatory Flags
- DUNS number
- 305682023
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05707480135363 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 520611101 | 520611101 | 2017-10-13 |
| 05707480135585 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523631011 | 523631011 | 2018-07-09 |
| 05707480135615 | SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator | 530639011 | 530639011 | 2017-10-13 |
| 05707480136018 | SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator | 544216047 | 544216047 | 2018-05-28 |
| 05707480145294 | SPUR® II Adult Resuscitator | 524614000 | 524614000 | 2020-06-24 |
| 05707480145317 | SPUR® II Pediatric Resuscitator | 531616000 | 531616000 | 2020-06-24 |
| 05707480145348 | SPUR® II Adult Resuscitator | 520611074 | 520611074 | 2020-06-24 |
| 05707480145393 | SPUR® II Adult Resuscitator | 520211000BE | 520211000BE | 2021-04-13 |
| 05707480145416 | SPUR® II Adult Resuscitator | 520211000E | 520211000E | 2021-04-13 |
| 05707480145430 | SPUR® II Adult Resuscitator | 520211001E | 520211001E | 2021-04-13 |
| 05707480145454 | SPUR® II Adult Resuscitator | 520211010E | 520211010E | 2021-04-13 |
| 05707480145478 | SPUR® II Adult Resuscitator | 520214000E | 520214000E | 2021-04-13 |
| 05707480145492 | SPUR® II Adult Resuscitator | 520611000E | 520611000E | 2021-04-13 |
| 05707480145515 | SPUR® II Adult Resuscitator | 521611000E | 521611000E | 2021-04-13 |
| 05707480145539 | SPUR® II Adult Resuscitator | 523211000E | 523211000E | 2021-04-13 |
| 05707480145553 | SPUR® II Adult Resuscitator | 523211001E | 523211001E | 2021-04-13 |
| 05707480145577 | SPUR® II Adult Resuscitator | 523611030E | 523611030E | 2021-04-13 |
| 05707480145591 | SPUR® II Adult Resuscitator | 523611031E | 523611031E | 2021-04-13 |
| 05707480027354 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211000 | 523211000 | 2016-12-19 |
| 05707480027361 | SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator | 523211001 | 523211001 | 2016-12-19 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850081334033 | Zenflow Spring® Scope | ZENFLOW, INC. | FAJ | 2026-05-22 |
| 00850081334057 | Zenflow Camera Control Unit | ZENFLOW, INC. | FAJ | 2026-05-22 |
| 00848657023122 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657023139 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657068956 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657069236 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657069243 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657069250 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657069618 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657074889 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657075060 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657075084 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657075244 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657075725 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657076289 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657076692 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657078160 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657078177 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657078184 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657078191 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657086936 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00848657086943 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-23 |
| 00810116023431 | Dornier MedTech | DORNIER MEDTECH AMERICA, INC. | FAJ | 2026-01-22 |
| 06971176281729 | Eview | Zhuhai Pusen Medical Technology Co, Ltd | FAJ | 2026-01-22 |
| 06971176281965 | Eview | Zhuhai Pusen Medical Technology Co, Ltd | FAJ | 2026-01-22 |
| 06971176283570 | Foot Switch (HRF-M5 PS) | Zhuhai Pusen Medical Technology Co, Ltd | FAJ | 2026-01-22 |
| 00848657076845 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-15 |
| 00848657077040 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-15 |
| 00848657078061 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | FAJ | 2026-01-15 |
| 06972520302893 | Ascend™ Single-Use Flexible Cysto-Nephroscope HD | Guangzhou Red Pine Medical Instrument Co., Ltd. | FAJ | 2025-12-31 |