FDA UDI
In Commercial Distribution
🇺🇸 United States
aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use
DI: 05707480135509
·
Model: 477001000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use
- Primary DI
- 05707480135509
- Version / Model
- 477001000
- Catalog Number
- 477001000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-04
- Public Version
- 3
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 7d48193b-3592-4605-b6c8-fc34dcf98f18
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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | Bronchoscope (flexible or rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60963 | Flexible video bronchoscope, single-use | An 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 typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480135523 | GS1 | 4 | In Commercial Distribution | ||
| Package | 05707480135516 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 05707480135509 | GS1 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Lumen/Inner Diameter | 2.2 | Millimeter | |
| Length | 600 | Millimeter | |
| Device Size Text, specify | Size 4 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius