FDA UDI
In Commercial Distribution
🇺🇸 United States
KORU
DI: 00659443003118
·
Model: 348143
·
REPRO MED SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- KORU
- Primary DI
- 00659443003118
- Version / Model
- 348143
- Catalog Number
- 348143
- Company Name
- REPRO MED SYSTEMS, INC.
- Labeler DUNS
- 048403299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-18
- Public Version
- 1
- Public Version Date
- 2023-12-26
- Public Version Status
- New
- Public Device Record Key
- 45f52554-c647-4512-a7b7-d8fea5257dc4
Device Description
Freedom60 Prefilled Syringe Adapter
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FRN | Pump, infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46845 | Ambulatory non-insulin infusion pump, mechanical, reusable | A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA) by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00659443003132 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00659443003118 | GS1 |
Customer Contacts
- Phone
- +1(800)624-9600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231918 | 000 |