Duns Number:305682023
Device Description: Ambu aScope 4 Broncho Regular 5.0/2.2 Single-use and flexible brochoscope. Portable and st 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
Catalog Number
477001000
Brand Name
aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use
Version/Model Number
477001000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EOQ
Product Code Name
Bronchoscope (flexible or rigid)
Public Device Record Key
7d48193b-3592-4605-b6c8-fc34dcf98f18
Public Version Date
October 30, 2019
Public Version Number
2
DI Record Publish Date
July 04, 2018
Package DI Number
05707480135523
Quantity per Package
4
Contains DI Package
05707480135516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |