Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1734285909
Device Listing 1734285909
Listing Summary
#
Listing key
1734285909
Premarket submission
K250401
Device
AION TempShield™
Applicant
Aion Biosystems, Inc.
Product code
FLL
Decision date
2025-03-14
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
344011
3005841768
3005841768
REMEDYREPACK, INC.
1
N
2026-01-01
625 Kolter Drive Suite 4 Indiana PA US 15701