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Accuryn Monitor Mount with Clamp

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FGN-06-100202Model FGN-06-102112

by Potrero Medical, Inc.

Identity

Trade Name
Accuryn Monitor Mount with Clamp EUDAMEDFDA UDI
Generic Name
Portable active medical device mount FDA UDI
Device Name
Accuryn Monitor High Mount EUDAMED
The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob. FDA UDI
Model / Reference
FGN-06-102112 EUDAMED
FGN-06-100202 EUDAMEDFDA UDI
Description
The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob. FDA UDI

Identifiers

Catalog Number
FGN-06-100202 FDA UDI
Primary DI / UDI-DI
00850019755237 EUDAMEDFDA UDI
Basic UDI-DI
0850019755MountStand9C EUDAMED
Direct Marketing DI
00850019755237 EUDAMED
FDA Product Code
EZL FDA UDI
PHU FDA UDI
EXY FDA UDI
EMDN Code
U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
GMDN Term
Portable active medical device mount 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 Monitor Mount with Clamp 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 574c1bd1-03c8-43c9-9eb9-27b9fab72c43 61 fields · synced Oct 6, 2026
  • FDA UDI 7243e354-ebda-4d77-91cf-762d7b35cdc3 35 fields · synced May 30, 2026