FDA Registration
Active
🇺🇸 United States
REMEDYREPACK, INC.
Reg #: 3005841768
·
FEI: 3005841768
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- REMEDYREPACK, INC.
- Registration Number
- 3005841768
- FEI Number
- 3005841768
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 625 Kolter Drive, Suite 4
- City
- Indiana
- State
- PA
- ZIP
- 15701
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250401
Owner / Operator
- Firm Name
- RemedyRepack, Inc.
- Operator Number
- 10094058
- Address
- 625 Kolter Drive, Suite 4
- City
- Indiana
- State
- PA
- Postal Code
- 15701
- Country
- US
- Correspondent
- Susan Scott
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-11-18 |
Proprietary Names
AION TempShield
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device