Duns Number:053146767
Device Description: BE 150-5G Test Lung has a 22mm I.D. connection and a 1 liter capacity; Not made with natur BE 150-5G Test Lung has a 22mm I.D. connection and a 1 liter capacity; Not made with natural rubber latex. Not for patient use.
Catalog Number
BE 150-5G
Brand Name
BE 150-5G Test Lung
Version/Model Number
BE 150-5G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTC
Product Code Name
Bag, Reservoir
Public Device Record Key
8f6b3804-baee-4a3c-ac12-22875efef175
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
December 30, 2016
Package DI Number
M996BE1505G1
Quantity per Package
5
Contains DI Package
M996BE1505G0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock poly bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |