Ambu 10-601177-1
GUDID 20818634025146
Ambu aScope 4 Cysto 5/Box
Bosma Enterprises
Flexible video cystoscope, single-use| Primary Device ID | 20818634025146 |
| NIH Device Record Key | 0745a0b9-3960-4ca4-b8fe-7e192a556264 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambu |
| Version Model Number | 10-601177-1 |
| Catalog Number | 10-601177-1 |
| Company DUNS | 878070325 |
| Company Name | Bosma Enterprises |
| Device Count | 5 |
| 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 | false |
| 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 | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org | |
| Phone | 800-362-5463 |
| kimm@bosma.org |
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 |
| Lumen/Inner Diameter | 2.2 Millimeter |
| Outer Diameter | 6 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818634025142 [Unit of Use] |
| GS1 | 10818634025149 [Primary] |
| GS1 | 20818634025146 [Package] Contains: 10818634025149 Package: Case [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 | 2023-05-09 |
| Device Publish Date | 2023-05-01 |
On-Brand Devices [Ambu]
| 20818634025191 | Ambu aScope 4 Cysto Reverse Deflection 5/Box |
| 20818634025160 | Ambu aScope 4 Broncho Regular 5.0/2.2 5/Box |
| 20818634025153 | AMBU aScope 4 Broncho Slim 3.8/1.2 5/Box |
| 20818634025146 | Ambu aScope 4 Cysto 5/Box |
| 20818634025139 | Ambu aScope 4 RhinoLaryngo Slim 5/Box |
| 20818634025115 | Ambu aScope 4 Broncho Large 5.8/2.8 5/Box |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.