Duns Number:007941230
Device Description: Mask Oxygen Medium Concentration 7 Foot Kink-Resistant Tubing Dehp-Free Elastic Strap Pedi Mask Oxygen Medium Concentration 7 Foot Kink-Resistant Tubing Dehp-Free Elastic Strap Pediatric Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
RSP1010P
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
-
Product Code
BYG
Product Code Name
MASK, OXYGEN
Public Device Record Key
a51f00f8-a2de-45ba-b531-d9cb58618a02
Public Version Date
October 13, 2020
Public Version Number
1
DI Record Publish Date
October 05, 2020
Package DI Number
50885632124646
Quantity per Package
50
Contains DI Package
10885632124648
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |