Duns Number:002348191
Device Description: Pediatric Laryngo-Tracheal Mucosal Atomization Device with 5ml Oral Syringe
Catalog Number
MAD730OS
Brand Name
LMA
Version/Model Number
IPN046400
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"
-
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
K153470,K153470,K153470
Product Code
CCT
Product Code Name
APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA
Public Device Record Key
40dfda62-595d-45cd-80d0-bffb9f7bc4d9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
25060112313244
Quantity per Package
4
Contains DI Package
15060112313247
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |