Ambu® aScope™ 5 Cysto HD 603101000
GUDID 05707480164516
Flexible Cystoscope, Standard Deflection
Ambu A/S
Flexible video cystoscope, single-use| Primary Device ID | 05707480164516 |
| NIH Device Record Key | 50a3aa5d-f15d-48c0-9564-2345ed90cefb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambu® aScope™ 5 Cysto HD |
| Version Model Number | 603101000 |
| Catalog Number | 603101000 |
| Company DUNS | 305682023 |
| Company Name | Ambu A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com |
Device Dimensions
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480164493 [Primary] |
| GS1 | 05707480164509 [Package] Contains: 05707480164493 Package: [5 Units] In Commercial Distribution |
| GS1 | 05707480164516 [Package] Contains: 05707480164509 Package: [4 Units] In Commercial Distribution |
FDA Product Code
| FAJ | Cystoscope and accessories, flexible/rigid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-14 |
| Device Publish Date | 2024-11-06 |
On-Brand Devices [Ambu® aScope™ 5 Cysto HD]
| 05707480164516 | Flexible Cystoscope, Standard Deflection |
| 05707480164486 | Flexible Cystoscope, Reverse Deflection |
Trademark Results [Ambu]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMBU 98192535 not registered Live/Pending |
AMBU A/S 2023-09-22 |
 AMBU 90002202 not registered Live/Pending |
AMBU 2020-06-15 |
 AMBU 79051291 3554442 Live/Registered |
AMBU A/S 2008-02-15 |
 AMBU 74156351 1686178 Live/Registered |
AMBU A/S 1991-04-12 |
 AMBU 73438330 1330624 Dead/Cancelled |
Testa-Laboratorium A/S 1983-08-08 |
 AMBU 73023700 1040868 Dead/Expired |
TESTA-LABORATORIUM A/S 1974-06-10 |
 AMBU 72127671 0740102 Dead/Cancelled |
Testa Laboratorium A/S 1961-09-11 |
 AMBU 72055090 0705020 Dead/Cancelled |
TESTA LABORATORIUM A/S 1958-07-10 |
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