aScope™ 4 Broncho Large Sampler Set 5.8/2.8 478501000
GUDID 05707480146000
aScope 4 Broncho Large Sampler Set
Ambu A/S
Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use| Primary Device ID | 05707480146000 |
| NIH Device Record Key | 761ba727-1e4f-432f-a763-0b5a8311a30c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | aScope™ 4 Broncho Large Sampler Set 5.8/2.8 |
| Version Model Number | 478501000 |
| Catalog Number | 478501000 |
| 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 | 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 | +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 | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
| Lumen/Inner Diameter | 2.8 Millimeter |
| Outer Diameter | 5.8 Millimeter |
| Device Size Text, specify | 0 |
| Length | 600 Millimeter |
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| 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 Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| 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 Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| 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 Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| 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 Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| 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 Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480145997 [Package] Package: [4 Units] In Commercial Distribution |
| GS1 | 05707480146000 [Package] Contains: 05707480146017 Package: [5 Units] In Commercial Distribution |
| GS1 | 05707480146017 [Primary] |
FDA Product Code
| EOQ | Bronchoscope (flexible or 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 | 2021-09-24 |
| Device Publish Date | 2021-09-16 |
Devices Manufactured by Ambu A/S
| 05707480021697 - Disposable Face Masks | 2024-04-16 Ambu disposable face mask, size neonate |
| 05707480021703 - Disposable Face Masks | 2024-04-16 Face mask |
| 05707480021710 - Disposable Face Masks | 2024-04-16 Ambu disposable face mask, size toddler, with hook ring, |
| 05707480005635 - Disposable Face Masks | 2024-04-16 Ambu disposable face mask, size small adult/child, with hook ring |
| 05707480021734 - Disposable Face Masks | 2024-04-16 Ambu disposable face mask, size medium adult, with hook ring |
| 05707480021741 - Disposable Face Masks | 2024-04-16 Ambu disposable face mask, size large adult, with hook ring |
| 05707480150441 - Ambu® SPUR® II Pediatric Resuscitator | 2024-03-07 w/CO2 Detector |
| 05707480150786 - Ambu® SPUR® II Pediatric Resuscitator | 2024-03-07 w/Exhalation Filter |
Trademark Results [aScope]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASCOPE 87622427 not registered Live/Pending |
AMBU A/S 2017-09-26 |
 ASCOPE 75029396 2086451 Dead/Cancelled |
Ameritech Corporation 1995-12-07 |
 ASCOPE 73410374 not registered Dead/Abandoned |
NORTHWEST INSTRUMENT SYSTEMS, INC. 1983-01-21 |
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