Duns Number:658122049
Device Description: HP93111I-3U Infant PVC Resuscitator Kit, includes:HP-9333A PVC Manual Resuscitator Bag - HP93111I-3U Infant PVC Resuscitator Kit, includes:HP-9333A PVC Manual Resuscitator Bag - Infant x 1 pcHP-8401C #1 Air Cushion Mask x 1 pcHP-3306B Single-patient-use Reservoir Valve set x 1 pcHP-1108 Oxygen Tubing x 1 pc*Package: PE bag/set*
Catalog Number
-
Brand Name
HEADSTAR
Version/Model Number
HP93111I-3U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K002846
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
0dca0283-7e06-4322-9116-c565f06780e9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2017
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |