aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use
- Primary DI
- 05707480135523
- Brand
- aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use
- Company
- Ambu A/S
- Model
- 477001000
- Catalog number
- 477001000
- Device description
- Ambu aScope 4 Broncho Regular 5.0/2.2 Single-use and flexible brochoscope. Portable and sterile from the pack. Suitable for intubation, Airway inspection,tube check, BAL & BW procedures, PDT procedures Bending section: 180° up/180° down Insert cord diameter: 5.5 mm, working lenght: 600 mm Minimum purchase is 5 pcs = 1 box
- Published
- 2018-07-04
- Public version status
- Update
- 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 |
|---|---|
| EOQ | Bronchoscope (flexible or rigid) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05707480135516 | Package | GS1 | 5 | In Commercial Distribution |
| 05707480135523 | Package | GS1 | 4 | In Commercial Distribution |
| 05707480135509 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05707480135516 | 05707480135516 | 5707480135516 |
| 05707480135523 | 05707480135523 | 5707480135523 |
| 05707480135509 | 05707480135509 | 5707480135509 |
GMDN Terms
| Term | Definition |
|---|---|
| Flexible video bronchoscope, single-use | A sterile endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 600 | Millimeter |
| Lumen/Inner Diameter | 2.2 | Millimeter |
| Outer Diameter | 5 | 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 Temperature | 10 Degrees Celsius | 25 Degrees Celsius | |
| Storage Environment Temperature | 10 Degrees Celsius | 40 Degrees Celsius |
Sterilization Methods
| Method |
|---|
| Ethylene Oxide |
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
- true
- Sterilization required before use
- false
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