Identity
- Trade Name
- RMS Precision Flow Rate TubingTM FDA UDI
- Generic Name
- Mechanical infusion pump administration set FDA UDI
- Device Name
- Flow Control Infusion Tubing FDA UDI
- Model / Reference
- F500 FDA UDI
- Description
- Flow Control Infusion Tubing FDA UDI
Identifiers
- Catalog Number
- F500 FDA UDI
- Primary DI / UDI-DI
- 00659443000186 FDA UDI
- 510(k) Number
- K933652 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Mechanical infusion pump administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.014 Inch FDA UDI
Category: Mechanical infusion pump administration set
RMS Precision Flow Rate TubingTM by Repro Med Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical infusion pump administration set.
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- SUB-Q — EMED Technologies Corporation · Class II
- SAF-Q — EMED Technologies Corporation · Class II
- Primrose Medical, Inc — PRIMROSE MEDICAL, INC. · Class II
- OPTFlow — EMED Technologies Corporation · Class II
Cleared under the same submission
K933652 also covers:
- HIgH-Flo™ — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Repro Med Systems, Inc.
Sources (1)
- FDA UDI 9073a955-9f5b-448a-ab51-a0e7e17a9973 38 fields · synced Jun 1, 2026