FDA UDI
Not in Commercial Distribution
🇺🇸 United States
aScope BronchoSampler™Specimen Sampling System - Single Use
DI: 05707480137107
·
Model: 480200000
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- aScope BronchoSampler™Specimen Sampling System - Single Use
- Primary DI
- 05707480137107
- Version / Model
- 480200000
- Catalog Number
- 480200000
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-30
- Public Version
- 3
- Public Version Date
- 2023-04-13
- Public Version Status
- Update
- Public Device Record Key
- 262182b4-084c-4c80-a204-338999359040
- Distribution End Date
- 2023-04-12
Device Description
Ambu aScope BronchoSampler A Single-use, sterile and closed-loop system for bronchoscopic specimen sampling. Set included 2 container, 1 interface for sampling and 1 suction adapter. For integration with Ambu aScope 4 Broncho. Container volume 30ml, ETO sterilisation method. Minimum ordering is 5 pcs = 1 box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CBC | BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED) | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63649 | General-purpose surgical suction system, vacuum | An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480137114 | GS1 | 5 | Not in Commercial Distribution | 2023-04-12 | |
| Primary | 05707480137107 | GS1 | ||||
| Package | 05707480137121 | GS1 | 8 | Not in Commercial Distribution | 2023-04-12 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Storage Conditions
- Type
- Storage 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