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Ap409-01 Primary Infusion Set With Vented/Non-Vented Drip Chamber, Back Check Va
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Model / Reference
- 12005-000-0003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290109153060 FDA UDI
- 510(k) Number
- K192860 FDA UDI
- FDA Product Code
- PFA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1140 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
Category: Electric infusion pump administration set, single-use
Ap409-01 Primary Infusion Set With Vented/Non-Vented Drip Chamber, Back Check Va by Eitan Medical Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Electric infusion pump administration set, single-use.
- MODD1 Infusion Set, 10 Pack — Modular Medical, Inc. · Class II
- CompuDent-STA™ Drive Unit — MILESTONE SCIENTIFIC, INC. · Class II
- Clear-View Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- Alaris, SmartSite — BD Switzerland Sàrl · Class II
- Clear-View Multi-site Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- CADD — ICU MEDICAL, INC. · Class II
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC · Class II
- Infusomat® — B. BRAUN MEDICAL INC. · Class II
Cleared under the same submission
K192860 also covers:
- AP 223-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE, — EITAN MEDICAL LTD
- AP133-01- BLOOD SET WITH TWO NON-VENTED SPIKES, 2 ROLLER CLAMPS — EITAN MEDICAL LTD
- AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET — EITAN MEDICAL LTD
- AP206-01- INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE — EITAN MEDICAL LTD
- AP209-01 — EITAN MEDICAL LTD
- AP213-01-MICROBORE INFUSION SET WITH NON-VENTED SPIKE, SLIDE CLAMP, ADMINISTRATI — EITAN MEDICAL LTD
- AP214-01- MICROBORE YELLOW MARKED INFUSION SET WITH VENTED/NON-VENTED SPIK — EITAN MEDICAL LTD
- AP223-01- MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE, FILTER AND NEE — EITAN MEDICAL LTD
- AP240-01 MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETT — EITAN MEDICAL LTD
- AP240-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET — EITAN MEDICAL LTD
- AP402-01 — EITAN MEDICAL LTD
- AP402-01 MICROBORE EPIDURAL YELLOW MARKED WITH VENTD_NON-VENTED SPIKE — EITAN MEDICAL LTD
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
- Eitan Medical Ltd
Sources (1)
- FDA UDI 7d891346-95b0-42f7-a3a5-3e804bfa6e11 35 fields · synced May 30, 2026