Duns Number:200103823
Device Description: Infant Size Rescuer Manual Resuscitator with universal tubing and filter
Catalog Number
4025-U-F
Brand Name
Rescuer Manual Resuscitator
Version/Model Number
4025-U-F
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"
-
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
K993194,K993194
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
b56372b6-36c3-468c-8f40-3853800aa49a
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 2021
Package DI Number
B0024025UF3
Quantity per Package
12
Contains DI Package
B0024025UF0
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |