FDA UDI
In Commercial Distribution
🇺🇸 United States
FREEDOM60®
DI: 00659443000001
·
Model: F10050
·
REPRO MED SYSTEMS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FREEDOM60®
- Primary DI
- 00659443000001
- Version / Model
- F10050
- Catalog Number
- F10050
- Company Name
- REPRO MED SYSTEMS, INC.
- Labeler DUNS
- 048403299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f3b809fa-d1bc-48f2-ba65-2eeb27710c60
Device Description
Mechanical Syringe Infusion Pump
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKP | Immunoglobulin G (IgG) Infusion System | General Hospital | 880.5725 | 2 |
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
| FRN | Pump, infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46541 | Elastomeric infusion pump system filling device | A device that is used to fill an elastomeric infusion pump system chamber with a prescribed medicated solution, to create the pressure required to expand the elastic chamber and the subsequent force that infuses the solution into the patient/user when connected. The device typically holds a syringe prefilled with the solution, and has a handle or lever that is used to push the syringe plunger inward to force the solution into the elastomeric chamber. This device is typically designed for use by a layperson. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00659443000001 | GS1 |
Customer Contacts
- Phone
- +1(845)610-5587
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place