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SIRINGA PRERIEMPITA 5 ML 0, 9% NaCl- PENTAFLUSH
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 060022524510(k) K214080
Identity
- Trade Name
- SIRINGA PRERIEMPITA 5 ML 0,9% NaCl- PENTAFLUSH EUDAMED
- Device Name
- SIRINGA PRERIEMPITA EUDAMED
- Model / Reference
- 060022524 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015262000202 EUDAMED
- Basic UDI-DI
- 801526210854 EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
SIRINGA PRERIEMPITA 5 ML 0, 9% NaCl- PENTAFLUSH by Pentaferte Italia Srl — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
- BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
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- BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class II
- EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
- Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214080 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 801526210854 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Pentaferte Italia Srl
- EUDAMED SRN
- IT-MF-000040982
- FDA Applicant
- Pentaferte Italia S.R.L.
Sources (2)
- EUDAMED 50f212e6-8277-4356-87f7-e10845e45ae6 85 fields · synced Jun 18, 2026
- FDA 510(k) K214080 1 fields · synced May 18, 2026