Identity
- Trade Name
- Infuset FDA UDI
- Generic Name
- Mechanical infusion pump administration set FDA UDI
- Device Name
- Infuset-190, Flow Control Infusion set FDA UDI
- Model / Reference
- Infuset-190 FDA UDI
- Description
- Infuset-190, Flow Control Infusion set FDA UDI
Identifiers
- Catalog Number
- FP-0010008 FDA UDI
- Primary DI / UDI-DI
- 00817708020403 FDA UDI
- 510(k) Number
- K140133 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Mechanical infusion pump administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 51.76 Centimeter FDA UDITotal Volume — 0.14 Milliliter FDA UDI
Category: Mechanical infusion pump administration set
Infuset by EMED Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical infusion pump administration set.
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC. · Class II
- HIgH-Flo™ — REPRO MED SYSTEMS, INC. · Class II
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
- Primrose Medical, Inc — PRIMROSE MEDICAL, INC. · Class II
- RMS Precision Flow Rate TubingTM — REPRO MED SYSTEMS, INC. · Class II
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
- Flow Control Tubing — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
- AVID TruCustom — AVID MEDICAL, INC. · Class II
Cleared under the same submission
K140133 also covers:
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- Infuset — EMED Technologies Corporation
- infuset — EMED Technologies Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EMED Technologies Corporation
Sources (1)
- FDA UDI a9bbdcdb-e938-4496-b87e-88460085e1f1 38 fields · synced Jun 9, 2026