Duns Number:099674145
Device Description: Child, Disp, Resuscitator, 6
Catalog Number
L670-110
Brand Name
Life Support Products
Version/Model Number
L670-110
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"
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
K973106,K973106
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
b84e25bd-9f7d-4ac6-99cb-197d4fafed57
Public Version Date
May 05, 2020
Public Version Number
5
DI Record Publish Date
December 09, 2015
Package DI Number
20026072001237
Quantity per Package
6
Contains DI Package
00026072001233
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1099 |