Duns Number:025460908
Device Description: .5 Ltr. Hyperinflation Bag System
Catalog Number
5403
Brand Name
Teleflex/Hudson RCI
Version/Model Number
5403
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K925591,K925591
Product Code
BZR
Product Code Name
Mixer, breathing gases, anesthesia inhalation
Public Device Record Key
3e4f6ae3-3d4a-4705-92b0-9051cb9e57c6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 08, 2016
Package DI Number
40080196986218
Quantity per Package
20
Contains DI Package
10080196986217
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |