FDA UDI
In Commercial Distribution
🇺🇸 United States
RMS Precision Flow Rate TubingTM
DI: 00659443000209
·
Model: F900
·
REPRO MED SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- RMS Precision Flow Rate TubingTM
- Primary DI
- 00659443000209
- Version / Model
- F900
- Catalog Number
- F900
- 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
- 4
- Public Version Date
- 2024-04-03
- Public Version Status
- Update
- Public Device Record Key
- c58e203f-390b-4952-bbb2-246ebcb6b039
Device Description
Flow Control Infusion Tubing
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRN | Pump, infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46846 | Mechanical infusion pump administration set | A collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10659443000206 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 00659443000209 | GS1 |
Customer Contacts
- Phone
- +1(845)610-5587
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933652 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 0.014 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 30 Degrees Celsius