Ev1000

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: EV1000 FDA UDI
Generic Name: Patient positioning sensor FDA UDI
Device Name: HEART REFERENCE SENSOR BODY PADS FDA UDI
Model / Reference: EVHRSBP FDA UDI
Description: HEART REFERENCE SENSOR BODY PADS FDA UDI

Identifiers

Catalog Number: EVHRSBP FDA UDI
Primary DI / UDI-DI: 00690103193497 FDA UDI
510(k) Number: K140312 FDA UDI
K160552 FDA UDI
FDA Product Code: DSB FDA UDI
DXN FDA UDI
GMDN Term: Patient positioning sensor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2770 FDA UDI
870.1130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Patient positioning sensor

Ev1000 by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning sensor.

NGENIUS — Stryker Leibinger · Class II
Sherlock — Bard Access Systems, Inc. · Class II
V40 — MAKO Surgical Corp. · Class II
Patient tracker EM-D mini — Scopis GmbH · Class II
General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Sherlock — Bard Access Systems, Inc. · Class II
Calibration End Effector Inverted — MAKO Surgical Corp. · Class II
Sherlock — Bard Access Systems, Inc. · Class II

Cleared under the same submission

K140312 also covers:

K160552 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (1)

FDA UDI 81fe895f-4a9c-4edd-8ef2-3383930b4536 38 fields · synced Jun 8, 2026