← Back to catalogue

Freeflex+ Transfer Adapter

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 2870103

by Fresenius Kabi AG

Identity

Trade Name
Freeflex+ Transfer Adapter EUDAMED
freeflex+ FDA UDI
Generic Name
Fluid transfer set, general-purpose FDA UDI
Device Name
Transfer Devices EUDAMED
Reconstitute and/or admix drugs prior to administration to the patient. The device may be used for pediatric and adult populations. FDA UDI
Model / Reference
2870103 EUDAMED
Transfer Adapter FDA UDI
Description
Reconstitute and/or admix drugs prior to administration to the patient. The device may be used for pediatric and adult populations. FDA UDI

Identifiers

Catalog Number
2870103 FDA UDI
Primary DI / UDI-DI
04250273729931 EUDAMEDFDA UDI
Basic UDI-DI
42502737NIV50611s000000BC EUDAMED
510(k) Number
K212445 FDA UDI
FDA Product Code
LHI FDA UDI
EMDN Code
A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
GMDN Term
Fluid transfer set, general-purpose FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Market of Registration
Germany EUDAMED
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
MRI Safety
MR Safe FDA UDI

Freeflex+ Transfer Adapter by Fresenius Kabi AG — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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

Manufacturer

Manufacturer
Fresenius Kabi AG
EUDAMED SRN
DE-MF-000009273

Sources (3)

  • EUDAMED 4e511fb4-eeb1-424e-b784-e9e578b50306 61 fields · synced Jul 19, 2026
  • FDA UDI eae7c0e7-c5d6-4441-9ce2-ef67ec02b63e 36 fields · synced May 30, 2026
  • FDA 510(k) K212445 1 fields · synced May 18, 2026