Duns Number:022721133
Device Description: Oxygen Mask (Pediatric) Medium Concentration, 7’ (2,1 m) supply tube, elastic strap fixati Oxygen Mask (Pediatric) Medium Concentration, 7’ (2,1 m) supply tube, elastic strap fixation with female thread grip connector.
Catalog Number
1122TG-7
Brand Name
N/A
Version/Model Number
1122TG-7
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
-
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
-
Product Code
BYG
Product Code Name
MASK, OXYGEN
Public Device Record Key
89f8ac01-1a66-4a30-bd14-03a0002ddd05
Public Version Date
August 01, 2018
Public Version Number
5
DI Record Publish Date
June 09, 2017
Package DI Number
01067411940652
Quantity per Package
50
Contains DI Package
00607411940651
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |