Duns Number:367919120
Device Description: HMEF 1000/S With Flexible Tube and Elbow Connector, Disposable
Catalog Number
8570203
Brand Name
AirLife
Version/Model Number
8570203
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"
-
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
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
b7dc5bd5-2827-43a7-b5bb-5064ae286edf
Public Version Date
August 05, 2022
Public Version Number
7
DI Record Publish Date
September 14, 2016
Package DI Number
70885403255535
Quantity per Package
30
Contains DI Package
10885403255533
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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. | 363 |