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Accuryn Temperature Cable

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FGN-06-100779Model FGN-06-102306

by Potrero Medical, Inc.

Identity

Trade Name
Accuryn Temperature Cable EUDAMEDFDA UDI
Generic Name
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
Accuryn Temperature Cable Adapter EUDAMED
The Reusable Temperature Cable connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement. FDA UDI
Model / Reference
FGN-06-102306 EUDAMED
FGN-06-100779 EUDAMEDFDA UDI
Description
The Reusable Temperature Cable connects to a temperature-sensing Foley catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement. FDA UDI

Identifiers

Catalog Number
FGN-06-100779 FDA UDI
Primary DI / UDI-DI
00850019755008 EUDAMEDFDA UDI
Basic UDI-DI
0850019755TempCable95 EUDAMED
Direct Marketing DI
00850019755008 EUDAMED
FDA Product Code
EZL FDA UDI
PHU FDA UDI
EXY FDA UDI
EMDN Code
U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
GMDN Term
Electrical-only medical device connection cable, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
876.1800 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Accuryn Temperature Cable by Potrero Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Potrero Medical, Inc.
EUDAMED SRN
US-MF-000033318
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 2140c198-1471-43dc-b4d1-08fe863ad94a 61 fields · synced Jul 12, 2026
  • FDA UDI eff0f04f-0239-4781-8d3d-fd984489e19d 35 fields · synced May 30, 2026