← Back to catalogue

S Dispensing Line

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K192770Ref SDL-01-STDRef SDL-01-FIL

by Aea Srl

Identity

Trade Name
S Dispensing Line EUDAMED
APOTECA FDA UDI
Generic Name
Fluid transfer set, general-purpose FDA UDI
Device Name
S Dispensing Line EUDAMED
Transfer of liquid from a bag to syringes with APOTECAsyringe system FDA UDI
Model / Reference
SDL-01-STD EUDAMED
SDL-01-FIL EUDAMED
S Dispensing Line FDA UDI
Description
Transfer of liquid from a bag to syringes with APOTECAsyringe system FDA UDI

Identifiers

Catalog Number
SDL-01-STD FDA UDI
Primary DI / UDI-DI
05060304050823 EUDAMEDFDA UDI
05060304051035 EUDAMED
Basic UDI-DI
506030405SDLAU EUDAMED
510(k) Number
K192770 FDA 510(k)
FDA Product Code
FMF FDA 510(k)FDA UDI
LHI FDA UDI
EMDN Code
A0399 TUBULAR DEVICES - OTHER EUDAMED
GMDN Term
Fluid transfer set, general-purpose FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)FDA UDI
880.5440 FDA UDI
Market of Registration
Italy EUDAMED
Germany EUDAMED
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

The S Dispensing Line is a medical device classified as a fluid pathway device designed for controlled administration of fluids in clinical settings. It facilitates the precise delivery of liquids, such as medications, nutrients, or intravenous solutions, ensuring accurate dosing and flow regulation during patient care.

This device is intended for use in general hospital environments, supplied sterile and intended for single-use. It adheres to FDA 510(k) clearance (K192770) and MDR compliance, with a product code of FMF. Storage and handling must follow sterile medical device protocols to maintain integrity prior to use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aea Srl

Sources (4)

  • FDA 510(k) K192770 24 fields · synced Sep 18, 2026
  • FDA UDI 11c73b52-f3ad-4ef0-98db-9fbfc0089068 34 fields · synced May 30, 2026
  • EUDAMED 89585fa1-cea0-47f8-92d5-12c1371a4c2e 61 fields · synced Jul 9, 2026
  • EUDAMED b67678aa-65a0-4b55-b58e-b5c36b70fab0 61 fields · synced Jul 16, 2026