FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambu aView™ 2 Advance
DI: 05707480156757
·
Model: 405011000US2
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ambu aView™ 2 Advance
- Primary DI
- 05707480156757
- Version / Model
- 405011000US2
- Catalog Number
- 405011000US2
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 3
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- d5a4ed2a-f917-4d6a-b5f6-b1d443d65135
Device Description
Ambu aView 2 Advance (gen2) US CIB V2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 56654 | Endoscopic video image display unit | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05707480156757 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal