Duns Number:002657679
Device Description: Lil' Pacee preemie pacifier intended to soothe infants in the NICU especially for use with Lil' Pacee preemie pacifier intended to soothe infants in the NICU especially for use with respiratory products.
Catalog Number
15A
Brand Name
Pacee Pacifier
Version/Model Number
15A
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
-
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
MEF
Product Code Name
Ring, Teething, Non-Fluid Filled
Public Device Record Key
4cf87b92-3217-463c-a62f-ac881e2c4aa3
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
Package DI Number
10815090010023
Quantity per Package
100
Contains DI Package
00815090010026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX