Duns Number:038305402
Device Description: PEDIATRIC BAG, PEDIATRIC & INFANT MASK, W/ O2 RESERVOIR P/OFF W/MAN
Catalog Number
-
Brand Name
Ventlab
Version/Model Number
BT4013
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
K953107,K953107
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
675c0e11-6784-452b-98e5-ceb1ca08ea2a
Public Version Date
October 21, 2019
Public Version Number
3
DI Record Publish Date
November 23, 2016
Package DI Number
20889483091279
Quantity per Package
10
Contains DI Package
10889483091272
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 612 |