Duns Number:025460908
Device Description: .5 Ltr. Hyperinflation Bag System
Catalog Number
5402
Brand Name
Teleflex/Hudson RCI
Version/Model Number
5402
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)
Yes
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
K925591,K925591
Product Code
BZR
Product Code Name
Mixer, breathing gases, anesthesia inhalation
Public Device Record Key
52324b77-32aa-4f18-97ec-f3a2df6a7253
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 08, 2016
Package DI Number
40080196000631
Quantity per Package
20
Contains DI Package
10080196000630
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 |