Duns Number:785952607
Device Description: QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M (REPLACES QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M (REPLACES TRADITIONAL MASK SIZE 0-1)
Catalog Number
-
Brand Name
QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M
Version/Model Number
7191000
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
75edd842-e66c-4834-8fef-ae201cbe260b
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 25, 2021
Package DI Number
05030267079612
Quantity per Package
30
Contains DI Package
05030267079032
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |