Duns Number:051420107
Device Description: Trach Care Set Standard MMC mfr# 82763
Catalog Number
-
Brand Name
Moore Medical
Version/Model Number
82763MMC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NXA
Product Code Name
Kit, Tracheotomy Care
Public Device Record Key
d55123fd-e9c1-406b-80d0-b8142c5c6286
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 09, 2016
Package DI Number
40607415001288
Quantity per Package
24
Contains DI Package
10607415001270
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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |