aScope™ 4 RhinoLaryngo Slim
- Primary DI
- 05707480146277
- Brand
- aScope™ 4 RhinoLaryngo Slim
- Company
- Ambu A/S
- Model
- 510005000
- Catalog number
- 510005000
- Device description
- aScope 4 RhinoLaryngo Slim (20 pcs)
- Published
- 2021-05-17
- 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
Product Codes
| Code | Name |
|---|
| EOB | Nasopharyngoscope (flexible or rigid) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05707480146260 | Package | GS1 | 4 | In Commercial Distribution |
| 05707480146277 | Package | GS1 | 5 | In Commercial Distribution |
| 05707480146284 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05707480146260 | 05707480146260 | 5707480146260 |
| 05707480146277 | 05707480146277 | 5707480146277 |
| 05707480146284 | 05707480146284 | 5707480146284 |
GMDN Terms
| Term | Definition |
|---|
| Flexible video otorhinolaryngoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Length | 300 | Millimeter |
| Outer Diameter | 3 | Millimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 80 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 30 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 50 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Humidity | 30 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
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
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|---|
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| 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
ambuusa.com