Duns Number:544436531
Device Description: KM-101 is a quick, inexpensive, easy to use resuscitation sheet with a one-way valve meant KM-101 is a quick, inexpensive, easy to use resuscitation sheet with a one-way valve meant to provide a safe barrier between you and your patient. This CPR mask prevents your mouth, nose and face from coming into direct contact with the other person and is designed to stay securely in place during the procedure.
Catalog Number
-
Brand Name
Konmed
Version/Model Number
CPR Mask Keyring Mode:KM-101
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
b7220db4-101f-479a-ab3d-2fca0434bf9d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |